510(k) K901974
- Device
- SELECTOR ULTRASONIC SURGICAL ASPIRATOR
- Applicant
- SPEMBLY MEDICAL LTD.
- 510(k) number
- K901974
- Product code
- LFL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-05
- Date received
- 1990-05-01
- 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
- Third party reviewed
- No
Applicant Contact#
- Contact
- F GIBSON
- Address
- Newbury Rd. Andover Hampshire Sp10 4dr England GB
FDA Registration Numbers#
- 3007713438
- 2133786
- 3026612481
- 2032112
- 3009380063
- 3014279513
- 3010493171
- 3009719225
- 3010432890
- 3013188547
- 3003800159
- 3030153385
- 2030598
- 3015967359
- 1721686
- 1319639
- 3013077751
- 3007997036
- 3015540957
- 1717344
- 3021194552
- 1721676
- 1056553
- 3013868968
- 2183744
- 1724474
- 1928237
- 3017820152
- 3021970868
- 3015183635
- 3014461810
- 3010684280
- 8010177
- 2182291
- 3015153469
- 3014479313
- 1721983
- 3027669735
- 3017619652
- 3035387162
- 3018094310
- 3015895145
- 2435119
- 3013111980
- 3005646850
- 8043817
- 3012507533
- 1722447
- 1219930
- 1018470
- 9610773
- 3009941480
- 3022626486
- 3008837339
- 3004530184
- 9614641
- 2648988
- 3008309062
- 3010760216
- 9710649
- 3016607092
- 2183967
- 1650907
- 3017636737
- 3010408671
- 3002807314
- 3009350690
- 3011024991
- 3031800723
- 3004608878
- 1643817
- 3004636440
- 3040335671
- 3004111573
- 3030733800
- 3016096100
- 2011171
- 3012494290
- 3005075853
- 3014635169
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LFL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261361 | TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet) | Carl Zeiss Meditec, AG | 2026-10-15 |
| K262244 | Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade (5500-26B-010); Sonopet iQ+ 20mm iQ+ Blade (5500-26B-020); Sonopet iQ+ 11cm iQ+ Apex Knife (5500-26B-114); Sonopet iQ+ 12cm iQ+ Apex 360 (5500-26B-312); Sonopet iQ+ 12cm iQ+ Claw (5500-26B-328) | Stryker Instruments | 2026-10-08 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases