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FDA 510(k)

MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM

K-Number: K983065 · 1998-12-01

ApplicantMentor Corp.
Decision Date1998-12-01
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1998-12-01 under 510(k) number K983065. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM?

MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-01. The listed applicant is Mentor Corp.. The 510(k) number is K983065.

When did MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM receive FDA 510(k) clearance?

MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM received FDA 510(k) clearance on 1998-12-01, under 510(k) number K983065.

Who is the listed applicant for MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM?

The FDA 510(k) record lists Mentor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM?

The FDA product code for MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM is LFL.

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Other records listing Mentor Corp. as applicant

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Related Devices (Code: LFL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLCK251162CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK242894SanAgile™ 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.K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker InstrumentsK241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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