Bovie Ultrasonic Surgical Aspirator

FDA 510(k) K932094 · Mdt Corp., Inc.

Substantially Equivalent

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

Official FDA 510(k) record

Device classification

Product code
LFL – Instrument, Ultrasonic Surgical
Device class
Unclassified

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K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic…LFL · Traditional Shanghai Saints Sages Surgical Co., Ltd.06/18/2025SE
K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional Stryker Instruments03/24/2025SE
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K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional Integra LifeSciences Corporation07/11/2024SE
K233036Ultrasonic Surgical SystemLFL · Traditional Hunan Handlike Minimally Invasive Surgery Co.…06/18/2024SE
K230427CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional Integra LifeSciences Corporation07/11/2023SE
K231117neXus Ultrasonic Surgical Aspirator SystemLFL · Special Misonix, LLC, A Bioventus Company06/23/2023SE
K221790HARMONIC 700 ShearsLFL · Traditional Ethicon Endo-Surgery, LLC02/28/2023SE

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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.