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FDA 510(k)

ULTRACISION 5MM INSTRUMENTS

K-Number: K983316 · 1998-10-21

ApplicantEthicon Endo-Surgery, Inc.
Decision Date1998-10-21
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

ULTRACISION 5MM INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, Inc.. It received FDA 510(k) clearance on 1998-10-21 under 510(k) number K983316. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACISION 5MM INSTRUMENTS?

ULTRACISION 5MM INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1998-10-21. The listed applicant is Ethicon Endo-Surgery, Inc.. The 510(k) number is K983316.

When did ULTRACISION 5MM INSTRUMENTS receive FDA 510(k) clearance?

ULTRACISION 5MM INSTRUMENTS received FDA 510(k) clearance on 1998-10-21, under 510(k) number K983316.

Who is the listed applicant for ULTRACISION 5MM INSTRUMENTS?

The FDA 510(k) record lists Ethicon Endo-Surgery, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRACISION 5MM INSTRUMENTS?

The FDA product code for ULTRACISION 5MM INSTRUMENTS is LFL.

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Other records listing Ethicon Endo-Surgery, Inc. 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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