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FDA 510(k)

OLYMPUS FB SERIES BIOPSY FORCEPS

K-Number: K955065 · 1996-01-24

ApplicantOlympus America, Inc.
Decision Date1996-01-24
Product CodeFCL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS FB SERIES BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1996-01-24 under 510(k) number K955065. The device is classified under product code FCL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS FB SERIES BIOPSY FORCEPS?

OLYMPUS FB SERIES BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1996-01-24. The listed applicant is Olympus America, Inc.. The 510(k) number is K955065.

When did OLYMPUS FB SERIES BIOPSY FORCEPS receive FDA 510(k) clearance?

OLYMPUS FB SERIES BIOPSY FORCEPS received FDA 510(k) clearance on 1996-01-24, under 510(k) number K955065.

Who is the listed applicant for OLYMPUS FB SERIES BIOPSY FORCEPS?

The FDA 510(k) record lists Olympus America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS FB SERIES BIOPSY FORCEPS?

The FDA product code for OLYMPUS FB SERIES BIOPSY FORCEPS is FCL.

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Other records listing Olympus America, Inc. as applicant

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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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Related Devices (Code: FCL)

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.

K032092OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPEOlympus Optical Co., Ltd.K973611SPECTRASCIENCE REUSABLE BIOPSY FORCEPSSpectrascience, Inc.K971315AUXILIARY INSTRUMENTS FOR URSRichard Wolf Medical Instruments Corp.K964120INJECTO FLUSHRobert J. Jynch, Jr.K963517SPECTRA SCIENCE BIOPSY FORCEPSSpectrascience, Inc.K952863FORCEPS, BIOPSY, NON-ELECTRICAnnex Medical, Inc.

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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