510(k) K090864
- Device
- CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
- Applicant
- INTEGRA RADIONICS, INC.
- 510(k) number
- K090864
- Product code
- LFL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-08
- Date received
- 2009-03-30
- Regulation
- 510(k) Premarket Notification
- Classification name
- Instrument, Ultrasonic Surgical
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN J O'CONNELL
- Address
- 22 Terry Ave. Burlington MA US 01803 01803
FDA Registration Numbers#
- 3021194552
- 3026612481
- 8010047
- 3015967359
- 2011171
- 1061124
- 3032391
- 3016096100
- 8043817
- 3003724334
- 3010432890
- 3010188783
- 9616696
- 3001592626
- 9613895
- 3015173212
- 3004111573
- 2183967
- 3005075853
- 1650907
- 1724474
- 3010141593
- 2648666
- 1056128
- 1721983
- 3004636440
- 3012507533
- 2182291
- 3021970868
- 2183744
- 3040335671
- 3005646850
- 2183715
- 3010408671
- 2133786
- 3013875599
- 3009350690
- 9610773
- 3025663926
- 1928237
- 3013111980
- 2435119
- 2030598
- 3015540957
- 3009747810
- 1319639
- 3006697299
- 3011050570
- 1018470
- 3001675293
- 1219930
- 3007997036
- 3009750704
- 9710649
- 3009265194
- 3003418325
- 3010594949
- 8010177
- 3013283620
- 3013557562
- 1722139
- 3041274936
- 3011024991
- 3017636737
- 3007829657
- 3011989923
- 3002807314
- 1417592
- 3003800159
- 2648988
- 3007014520
- 9614641
- 1722447
- 3030153385
- 3027669735
- 3014279513
- 2032112
- 3011823740
- 3007713438
- 3021599290
Source Documents#
Other 510(k) Records For Product Code LFL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K212614 | Ultrasonic Scalpel System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2022-07-18 |
Legacy Summary#
summary
FDA Review#
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