Product code LFL
- Device name
- Instrument, Ultrasonic Surgical
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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... | 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 |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2022-07-15 |
| K212049 | Oclet TDS 1000 | Tendonova Corporation | 2022-03-08 |
| K213824 | Sonopet iQ Ultrasonic Aspirator System | Stryker Corporation | 2022-02-03 |
| K212060 | neXus Ultrasonic Surgical Aspirator System | Misonix, Inc. | 2021-12-13 |
| K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | Covidien, LLC | 2021-11-15 |
| K212750 | Ultrasonic Surgical Aspirator System, Model: XD880B | Smtp Technology Co., Ltd. | 2021-09-27 |
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021-08-04 |
| K202299 | Ultrasonic Surgical Aspirator System | Smtp Technology Co., Ltd. | 2021-05-21 |
| K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray | Ethicon Endo-Surgery, LLC | 2021-05-21 |
| K200427 | Sonicision Cordless Ultrasonic Dissector | Covidien, LLC | 2020-07-10 |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Integra LifeSciences Corporation | 2020-06-23 |
| K192963 | Kogent Torus Ultrasonic Aspirator | Katalyst Surgical, LLC | 2020-06-19 |
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | Ethicon Endo-Surgery, LLC | 2020-02-28 |
| K190281 | Ultrasonic Surgical System | Medisonic Technology CO | 2019-10-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10884521807884 | Sonicision | Covidien LP | 2020-06-29 |
| 10884521195202 | Sonicision | Covidien LP | 2018-08-10 |
| 04953170235665 | SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 34cm | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 04953170235153 | SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cm | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 04953170235122 | SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cm | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 04953170235030 | SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cm | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 04953170234941 | SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cm | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 04953170234880 | SonoSurg Curved Scissors,Pistol Grip,5mm x 34cm | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 04953170234859 | SonoSurg Straight Scissors,Pistol Grip,5mm x 34cm | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 04953170142628 | SonoSurg Transducer | OLYMPUS MEDICAL SYSTEMS CORP. | 2017-10-06 |
| 07613252026525 | Spetzler, Claw | STRYKER CORPORATION | 2016-09-23 |
| 07613252026501 | Spetzler, Barracuda | STRYKER CORPORATION | 2016-09-23 |
| 07613252026495 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613252026488 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613252026471 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613252026464 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613252026457 | NA | STRYKER CORPORATION | 2016-09-23 |
| 07613252026518 | NA | STRYKER CORPORATION | 2016-09-23 |
| 04953170308475 | Adapter for UHI-2/3 | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170308499 | Docking fixture | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170308451 | Communication cable 10 m | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170308437 | Communication Cable 0.25m | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170308413 | Footswitch for THUNDERBEAT | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170308390 | Footswitch for SONICBEAT | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170306808 | SONICBEAT Transducer | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170306778 | THUNDERBEAT Transducer | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170306754 | Ultrasonic Generator | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170306747 | Ultrasonic Generator | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170208485 | Cleaning brush | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170054358 | Brush | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |