510(k) · Cleared
Recalled · Class II · 2014Cusa Excel Ultrasonic Surgical Aspirator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valleylab, Inc. · LFL Instrument, Ultrasonic Surgical
Cleared on Jul 6, 1998 as substantially equivalent to K921251 (Valleylab, Inc., 1992) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1988. 89 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 6, 1998
- Review
- 90 days
- Class
- Class U
- Product code
- LFL
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 1 generation to K884413 (1988). 4 ancestors in all. 89 later devices descend from it, 11 citing it directly.
- Root · 1 generation backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- This deviceK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998
- Descendant · cites it directly · 49 of its ownK991791 Sound Vaser SystemSound Surgical Technologies, LLC · 1999 · Recalled
- Descendant · 2 generations on · 48 of its ownK022051 Soundvaser SystemSound Surgical Technologies, LLC · 2002 · Recalled
- Descendant · 3 generations on · 36 of its ownK042261 Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004
- Descendant · 4 generations on · 34 of its ownK072587 Cytori Aft SystemCytori Therapeutics, Inc. · 2007
- Descendant · cites it directly · 29 of its ownK051947 Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
Showing 5 of 89 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 89 · See all- K991791Sound Vaser SystemSound Surgical Technologies, LLC · 1999 · cites it directly49descendants
- K022051Soundvaser SystemSound Surgical Technologies, LLC · 2002 · 2 generations on48descendants
- K042261Macropore Puricel Lipoplasty SystemMacropore Biosurgery, Inc. · 2004 · 3 generations on36descendants
- K072587Cytori Aft SystemCytori Therapeutics, Inc. · 2007 · 4 generations on34descendants
- K051947Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005 · cites it directly29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| 0 (this device) | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | — |
| +1 | K991791 | Sound Vaser System | Sound Surgical Technologies, LLC | 1999 | 2 |
| +2 | K022051 | Soundvaser System | Sound Surgical Technologies, LLC | 2002 | 2 |
| +3 | K042261 | Macropore Puricel Lipoplasty System | Macropore Biosurgery, Inc. | 2004 | — |
| +4 | K072587 | Cytori Aft System | Cytori Therapeutics, Inc. | 2007 | — |
| +1 | K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone | Radionics, A Division of Tyco Healthcare Group LP | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K921251 | Cusa System 200C and 200T Ultrasonic AspiratorSummary page 3…Handpiece, and Accessories) is substantially equivalent in function and intended use to the following legally marketed devices: . Valleylab CUSA System 200 (510(k)'s K#921251, K#931902, K#934628) This console system operates at a frequency of 23kHz. The above submissions included 23kHz handpieces (CUSA… | 1992 |
| * | K931902 | Cusa System 200C/T Ultrasonic Aspirator & Access.Summary page 3…, and Accessories) is substantially equivalent in function and intended use to the following legally marketed devices: . Valleylab CUSA System 200 (510(k)'s K#921251, K#931902, K#934628) This console system operates at a frequency of 23kHz. The above submissions included 23kHz handpieces (CUSA PFT Ultras… | 1994 |
| * | K934628 | Cusa (R) Syst 200CT/200T Ultra Aspir Lap/Cem AccessSummary page 3…ssories) is substantially equivalent in function and intended use to the following legally marketed devices: . Valleylab CUSA System 200 (510(k)'s K#921251, K#931902, K#934628) This console system operates at a frequency of 23kHz. The above submissions included 23kHz handpieces (CUSA PFT Ultrasonic Handp… | 1995 |
| * | K884413 | Cusa System 200H Ultrasonic Surgical AspiratorSummary page 3…kHz. The above submissions included 23kHz handpieces (CUSA PFT Ultrasonic Handpiece) and system accessories. . Valleylab CUSA System 200H with 37kHz Handpiece (510(k) K#884413). This smaller handpiece operates at a higher frequency (37kHz) for applications which demand greater precision and user visibili… | 1988 |
What descends from it? (89)
See all 8911 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991791 | Sound Vaser System | 1999 | 49 |
| K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone | 2005 | 29 |
| K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model OM 1530000M3 | 2002 | 23 |
| K042277 | Selector Quantum Ultrasonic Aspirator System | 2004 | 17 |
| K141668 | Cusa Excel+ Ultrasonic Surgical Aspirator System | 2014 | 14 |
| K102258 | Cusa NXT Extended Length Tip | 2011 | 2 |
| K032066 | Sonosurg System | 2003 | 1 |
| K141674 | Cusa Excel+ Ultrasonic Surgical Aspirator System | 2014 | 0 |
| K090864 | Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator System | 2009 | 0 |
| K041566 | Sonosurg Ultrasonic Surgical System | 2004 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2014 | Class II | Z-1522-2014 | Under Investigation by firm | Some 23 kHz Torque Wrenches were incorrectly assembled and contained a 36 kHz Hex Wrench Insert instead of the 23 kHz Hex Wrench Insert. |
| Jan 7, 2013 | Class II | Z-0920-2013 | Nonconforming Material/Component | There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact… |
| Oct 14, 2011 | Not classified | Z-1215-2012 | Release of Material/Component prior to receiving test results | A small number of non-conforming CUSA Excel 23 KHz Standard Tip and flue (item Number C4601S) were released for distribution that did not meet Integra's in-process requirements for release. It was discovered during in-process inspection… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and Affiliated Organ Surgery, Urological Surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery, and 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/K981262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981262: 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/K981262
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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