510(k) · Cleared
ClearedCUSA 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 Sep 28, 2017 as substantially equivalent to K150682 (Integra Lifesciences Corp., 2015) after a 30-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Sep 28, 2017
- Review
- 30 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K884413 (1988). 10 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK884413 Cusa System 200H Ultrasonic Surgical AspiratorValleylab, Inc. · 1988
- 4 generations backK981262 Cusa Excel Ultrasonic Surgical Aspirator SystemValleylab, Inc. · 1998 · Recalled
- 3 generations backK051947 Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneRadionics, A Division of Tyco Healthcare Group LP · 2005
- 2 generations backK141668 Cusa Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2014
- 1 generation backK150682 CUSA Excel+Integra Lifesciences Corp. · 2015
- This deviceK172595 CUSA Excel+ Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K884413 | Cusa System 200H Ultrasonic Surgical Aspirator | Valleylab, Inc. | 1988 | — |
| −4 | K981262 | Cusa Excel Ultrasonic Surgical Aspirator System | Valleylab, Inc. | 1998 | 3 |
| −3 | K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with Bone | Radionics, A Division of Tyco Healthcare Group LP | 2005 | — |
| −2 | K141668 | Cusa Excel+ Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2014 | — |
| −1 | K150682 | CUSA Excel+ | Integra Lifesciences Corp. | 2015 | — |
| 0 (this device) | K172595 | CUSA Excel+ Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2017 | — |
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? (1)
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 |
|---|---|---|---|
| * | K150682 | CUSA Excel+Summary page 4…keted device(s) to which equivalence is claimed Trade or Propriety Name CUSA® Excel+ Ultrasonic Surgical Aspirator System 510(k) Number K150682 Product Code LFL, LBK Manufacturer Integra LifeSciences Corporation… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 10 ancestors have a recall of any class.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue in the following surgical specialties: Neurosurgery, Orthopedic Surgery, Plastic and Reconstructive 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…
Read the full statement (203 words)
The CUSA® Excel+ Ultrasonic Surgical Aspirator System is indicated for fragmentation, emulsification and aspiration of
soft and hard (e.g.: bone) tissue in the following surgical specialties:
Neurosurgery, Orthopedic Surgery, Plastic and Reconstructive 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
Gynecological Surgery — including removal of dysplastic genital or perianal epithelial tissue including vulvar and vaginal
intraepithelial neoplasia, removal of condyloma, debulking of metastatic uterine, ovarian, fallopian tube or primary
peritoneal carcinoma, and open or laparoscopic excision of tissue and adhesions associated with endometriosis
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/K172595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172595: 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/K172595
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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