Bovie Ultrasonic Surgical Aspirator
FDA 510(k) K932094 · Mdt Corp., Inc.
510(k) numberK932094
Submission
- Device name
- Bovie Ultrasonic Surgical Aspirator
- Applicant
- Mdt Corp., Inc.
Salt Lake City, UT, US - Received
- April 30, 1993
- Decision date
- July 21, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFL – Instrument, Ultrasonic Surgical
- Device class
- Unclassified
Other 510(k)s with product code LFL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, LLC | 07/30/2026SE |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 10/08/2025SE |
| K242894 | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic…LFL · Traditional | Shanghai Saints Sages Surgical Co., Ltd. | 06/18/2025SE |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | Stryker Instruments | 03/24/2025SE |
| K241700 | Tenex 2nd Generation SystemLFL · Traditional | Trice Medical, Inc. | 11/18/2024SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2024SE |
| K233036 | Ultrasonic Surgical SystemLFL · Traditional | Hunan Handlike Minimally Invasive Surgery Co.… | 06/18/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2023SE |
| K231117 | neXus Ultrasonic Surgical Aspirator SystemLFL · Special | Misonix, LLC, A Bioventus Company | 06/23/2023SE |
| K221790 | HARMONIC 700 ShearsLFL · Traditional | Ethicon Endo-Surgery, LLC | 02/28/2023SE |
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| K942486 | Image Full Power Examination/Minor Surgery TableFQO · Traditional | 08/10/1994SE |
| K924380 | Mdt/Harvey Model 7000 & 8000 ChemiclaveMLR · Traditional | 02/16/1994SE |
| K926081 | Dental LightEAZ · Traditional | 01/26/1994SE |
| K924955 | Mdt/Harvey MC-8 and MC-10FLE · Traditional | 10/15/1993SE |
| K931169 | MDT Dental ChairKLC · Traditional | 05/20/1993SE |
| K920930 | Mdt/Castle 10/90 Dual Load StationFLF · Traditional | 03/31/1993SE |
| K922212 | MDT Castle Biosign Test PackFRC · Traditional | 08/10/1992SE |
| K914758 | Mdt/Shampaine Model 4900B Surgical TableGDC · Traditional | 12/19/1991SE |
Questions and answers
When was Bovie Ultrasonic Surgical Aspirator cleared by the FDA?
Bovie Ultrasonic Surgical Aspirator (K932094) received a 510(k) decision of Substantially Equivalent on July 21, 1993, 82 days after the submission was received.
What is the product code of K932094?
The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.