510(k) · Cleared
Recalled · Class II · 2024Cusa Excel+ 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 Nov 6, 2014 as substantially equivalent to K981262 (Valleylab, Inc., 1998) and 1 other predicate after a 136-day review. Its family tree reaches back 3 generations to 1988. It has been recalled once.
- Decided
- Nov 6, 2014
- Review
- 136 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K884413 (1988). 8 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- Root · 3 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 2 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 1 generation backK051947 Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
- This deviceK141674 Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −2 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −1 | K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone | Radionics, A Division of Tyco Healthcare Group LP | 2005 | — |
| 0 (this device) | K141674 | Cusa Excel+ Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K981262 | Cusa Excel Ultrasonic Surgical Aspirator SystemSummary page 4…ation Unclassified Product Code(s) LFL, LBK 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed CUSA® Excel Ultrasonic Surgical Aspirator System K981262 CUSA" Excel Ultrasonic Surgical Aspirator System with Bone Tip K051947 807.92(a)(4) - Device description The CUSA Excel+ Ultras… | 1998 |
| * | K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneSummary page 4…rketed device(s) to which equivalence is claimed CUSA® Excel Ultrasonic Surgical Aspirator System K981262 CUSA" Excel Ultrasonic Surgical Aspirator System with Bone Tip K051947 807.92(a)(4) - Device description The CUSA Excel+ Ultrasonic Surgical Aspirator System is the current iteration of the previous… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 29, 2024 | Class II | Z-2167-2024 | Process design | Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 10 other devices also cite its predicate K981262.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 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® Excel+ Ultrasonic Surgical Aspirator System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:
* Neurosurgery
» Gastrointestinal and Affiliated Organ Surgery
» Urological Surgery
» Plastic and Reconstructive Surgery
* General Surgery
* Orthopedic Surgery
* Gynecological Surgery
* Thoracic Surgery
» Laparoscopic Surgery
» Thoracoscopic Surgery
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/K141674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141674: Cusa Excel+ Ultrasonic Surgical Aspirator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141674
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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