510(k) K190180
- Device
- CUSA Clarity Ultrasonic Surgical Aspirator System
- Applicant
- Integra LifeSciences Corporation
- 510(k) number
- K190180
- Product code
- LFL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-04-01
- Date received
- 2019-02-01
- Classification name
- Instrument, Ultrasonic Surgical
- Medical specialty
- Unknown
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alexandra Wells
- Address
- 311 Enterprise Dr. Planisboro NJ US 08536 08536
FDA Registration Numbers#
- 1417592
- 8043817
- 3010760216
- 3009380063
- 3013247477
- 3008309062
- 3025663926
- 1722139
- 3004111573
- 2133786
- 3013283620
- 3015895145
- 3021970868
- 3026606306
- 3015612252
- 3011120183
- 3013077751
- 3030733800
- 1643817
- 3010885402
- 3015967359
- 3015183635
- 3003724334
- 1650907
- 3009941480
- 3010141593
- 9610773
- 3004636440
- 3007829657
- 3040335671
- 3002808148
- 3014479313
- 9610612
- 3017820152
- 3012627460
- 1717344
- 3010273872
- 3009747810
- 1056128
- 3011050570
- 1724474
- 9613895
- 2182291
- 3007225330
- 1221053
- 3024490294
- 2183715
- 3001592626
- 3048246462
- 1056553
- 3016832577
- 3021194552
- 3027669735
- 1061124
- 1721983
- 3013665681
- 3012494290
- 2183967
- 3012507533
- 3022626486
- 3003800159
- 3030153385
- 3014279513
- 3014461810
- 3013868968
- 3010684280
- 3016607092
- 3013188547
- 3015540957
- 3007713438
- 3016555232
- 3032391
- 3033536319
- 9616696
- 3026612481
- 8010177
- 3016245399
- 1047843
- 3013557562
- 3004530184
Source Documents#
Other 510(k) Records For Product Code LFL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC | 2026-07-30 |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2025-10-08 |
| K242894 | SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) | Shanghai Saints Sages Surgical Co., Ltd. | 2025-06-18 |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Stryker Instruments | 2025-03-24 |
| K241700 | Tenex 2nd Generation System | Trice Medical, Inc. | 2024-11-18 |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2024-07-11 |
| K233036 | Ultrasonic Surgical System | Hunan Handlike Minimally Invasive Surgery Co., Ltd. | 2024-06-18 |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2023-07-11 |
| K231117 | neXus Ultrasonic Surgical Aspirator System | Misonix, LLC, A Bioventus Company | 2023-06-23 |
| K221790 | HARMONIC 700 Shears | Ethicon Endo-Surgery, LLC | 2023-02-28 |
| K223770 | Sonopet 1Q 3 7cm 1Q Large | Stryker Corporation | 2023-02-16 |
| K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5 | Sra Developments, Ltd. | 2022-12-15 |
| K210567 | Ultrasonic Surgical System | Miconvey Technologies Co., Ltd. | 2022-09-30 |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2022-08-22 |
| K221235 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2022-07-28 |