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FDA 510(k)

HARMONIC FOCUS SHEARS

K-Number: K100597 · 2010-04-07

ApplicantEthicon Endo-Surgery, LLC
Decision Date2010-04-07
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

HARMONIC FOCUS SHEARS is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2010-04-07 under 510(k) number K100597. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARMONIC FOCUS SHEARS?

HARMONIC FOCUS SHEARS is a medical device that received FDA 510(k) clearance on 2010-04-07. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K100597.

When did HARMONIC FOCUS SHEARS receive FDA 510(k) clearance?

HARMONIC FOCUS SHEARS received FDA 510(k) clearance on 2010-04-07, under 510(k) number K100597.

Who is the listed applicant for HARMONIC FOCUS SHEARS?

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

What is the FDA product code for HARMONIC FOCUS SHEARS?

The FDA product code for HARMONIC FOCUS SHEARS is LFL.

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Other records listing Ethicon Endo-Surgery, LLC 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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