510(k) · Cleared
Recalled · Class II · 2019CUSA Clarity Ultrasonic Surgical Aspirator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · LFL Instrument, Ultrasonic Surgical
Cleared on Dec 7, 2018 as substantially equivalent to K161882 (Integra LifeSciences Corporation, 2016) and 1 other predicate after a 65-day review. Its family tree reaches back 6 generations to 1988. 10 later devices descend from it. It has been recalled 42 times.
- Decided
- Dec 7, 2018
- Review
- 65 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 42
- Predicates
- 2
Its longest line of descent runs back 6 generations to K884413 (1988). 18 ancestors in all, the oldest K801623 (1980). 10 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 5 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 4 generations backK021989 Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3Integra Neurosciences · 2002 · Recalled
- 3 generations backK042277 Selector Quantum Ultrasonic Aspirator SystemIntegra Neurosciences, Ltd. · 2004
- 2 generations backK081459 Cusa Selector NXT Ultrasonic Tissue Ablation SystemIntegra Radionics, Inc. · 2008 · Recalled
- 1 generation backK161882 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2016 · Recalled
- This deviceK182809 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2018
- Descendant · cites it directly · 5 of its ownK200774 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2020
- Descendant · 2 generations on · 2 of its ownK221235 neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK231117 neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company · 2023
- Descendant · cites it directly · 1 of its ownK190180 CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2019
- Descendant · 4 generations on · 0 of its ownK261448 neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
2019high 3 (2022) · low 0 (2021)2026
Most influential descendants
Showing 5 of 10 · See all- K200774CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2020 · cites it directly5descendants
- K221235neXus Ultrasonic Surgical Aspirator SystemMisonix, Inc. · 2022 · 2 generations on2descendants
- K231117neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC, A Bioventus Company · 2023 · 3 generations on1descendant
- K190180CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2019 · cites it directly1descendant
- K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLC · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −5 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −4 | K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 | Integra Neurosciences | 2002 | 2 |
| −3 | K042277 | Selector Quantum Ultrasonic Aspirator System | Integra Neurosciences, Ltd. | 2004 | — |
| −2 | K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation System | Integra Radionics, Inc. | 2008 | 4 |
| −1 | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2016 | 2 |
| 0 (this device) | K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2018 | — |
| +1 | K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2020 | — |
| +2 | K221235 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2022 | — |
| +3 | K231117 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC, A Bioventus Company | 2023 | — |
| +1 | K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2019 | — |
| +4 | K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K161882 | CUSA Clarity Ultrasonic Surgical Aspirator SystemSummary page 4…) LFL, LBK 807.92(a)(3)- Legally Marketed Devices to Which Submitter Claims Equivalence CUSA® Clarity Ultrasonic Surgical Aspirator System K161882 CUSA® Excel+ Ultrasonic Surgical Aspirator System K141668 807.92(a)(4)- Device Description The CUSA® Clarity Ultrasonic Sur… | 2016 |
| * | K141668 | Cusa Excel+ Ultrasonic Surgical Aspirator SystemSummary page 4…ly Marketed Devices to Which Submitter Claims Equivalence CUSA® Clarity Ultrasonic Surgical Aspirator System K161882 CUSA® Excel+ Ultrasonic Surgical Aspirator System K141668 807.92(a)(4)- Device Description The CUSA® Clarity Ultrasonic Surgical Aspirator System was originally cleared October 14,… | 2014 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2019 | Class II | Z-0613-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0615-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0617-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0619-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0620-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0640-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0641-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0627-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0628-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0637-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0639-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0643-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0622-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0623-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0624-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0625-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0626-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0629-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0630-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0632-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0635-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0636-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0642-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0646-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0647-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0648-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0649-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0650-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0651-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0652-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0653-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0614-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0616-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0618-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0621-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0631-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0633-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0634-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0638-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0644-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0645-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
| Oct 21, 2019 | Class II | Z-0654-2020 | Device Design | The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes for the minimum Dry Time for the 36 kHz… |
The 5 latest of 42 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 4.2 years on median.
- 6 of the 18 ancestors have a recall of any class.
- Of its descendants, K200774 (Integra LifeSciences Corporation, 2020) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2007high 8 (2022) · low 1 (2009)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
2007high 241 (2011) · low 66 (2018)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
2007high 42 (2019) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
2007high 4,260 (2014) · low 1,053 (2011)2025
MAUDE reports naming product code LFL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in: Neurosurgery, Plastic and Reconstructive Surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses: Gastrointestinal and Affiliated Organ…
Read the full statement (173 words)
The CUSA® Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable.
The CUSA Clarity Ultrasonic Surgical Aspirator is indicated for use in:
Neurosurgery, Plastic and Reconstructive Surgery, Orthopedic Surgery, Gynecological Surgery and Thoracic Surgery and the following specific uses:
Gastrointestinal and Affiliated Organ Surgery – including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
Urological Surgery- including removal of renal parenchyma during nephrectomy or partial nephrectomy
General Surgery – including removal of benign or malignant tumors or other unwanted soft or hard tissue in open or minimally invasive general surgical procedures
Laparoscopic Surgery - including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182809 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182809: CUSA Clarity Ultrasonic Surgical Aspirator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182809
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026