Ultra-Safe Ultrasonic Aspirator System

FDA 510(k) K962525 · Morwel Corp.

Substantially Equivalent

510(k) numberK962525

Submission

Device name
Ultra-Safe Ultrasonic Aspirator System
Applicant
Morwel Corp.
Tucson, AZ, US
Received
June 27, 1996
Decision date
September 19, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LFL – Instrument, Ultrasonic Surgical
Device class
Unclassified

Other 510(k)s with product code LFL

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K261448neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional Misonix, LLC07/30/2026SE
K251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional Integra LifeSciences Corporation10/08/2025SE
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
K241700Tenex 2nd Generation SystemLFL · Traditional Trice Medical, Inc.11/18/2024SE
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

More from Ethicon Endo-Surgery, LLC

510(k)DeviceDecision
K841160Morwel AspiratorJCX · Traditional 05/31/1984SE
K841159Suction Tips · Traditional 03/19/1984SESP
K831520Morwel Cannula · Traditional 06/20/1983SE

Questions and answers

When was Ultra-Safe Ultrasonic Aspirator System cleared by the FDA?

Ultra-Safe Ultrasonic Aspirator System (K962525) received a 510(k) decision of Substantially Equivalent on September 19, 1996, 84 days after the submission was received.

What is the product code of K962525?

The FDA product code is LFL – Instrument, Ultrasonic Surgical, a Unclassified device.