510(k) K012028
- Device
- ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
- Applicant
- MISONIX, INC.
- 510(k) number
- K012028
- Product code
- LFL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-27
- Date received
- 2001-06-28
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ALBERT F CLANCY
- Address
- 1938 New Hwy. Farmingdale NY US 11735 11735
FDA Registration Numbers#
- 3013557562
- 9710649
- 3016096100
- 9614641
- 1319639
- 3013875599
- 2032112
- 3016607092
- 3011024991
- 3004530184
- 3017820152
- 1717344
- 3035387162
- 3026606306
- 3010408671
- 3013283620
- 1721686
- 3009116370
- 3014461810
- 3015540957
- 8010047
- 2182291
- 1056553
- 3011050570
- 3015224777
- 3012507533
- 2183715
- 1724474
- 3002807314
- 3024021261
- 3014479313
- 3033536319
- 3003724334
- 9610612
- 8043817
- 9613895
- 9616696
- 1417592
- 3013077751
- 3009750704
- 1056128
- 9610773
- 3015612252
- 1018470
- 3003418325
- 3007487007
- 3009380063
- 3010684280
- 3007829657
- 3004636440
- 1721983
- 3011063460
- 1722139
- 3014932737
- 3012627460
- 3032391
- 3017636737
- 3030153385
- 3011823740
- 1650907
- 3010141593
- 3015895145
- 3030733800
- 3013665681
- 3016555232
- 3025663926
- 3009719225
- 3012494290
- 2648988
- 2183967
- 2030598
- 3009747810
- 1527736
- 3014635169
- 3017619652
- 3005646850
- 3016832577
- 3013111980
- 3002808148
- 2133786
Source Documents#
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#
summary
FDA Review#
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