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FDA 510(k)

OLYMPUS FD-5 HOT BIOPSY FORCEPS

K-Number: K951445 · 1995-05-03

ApplicantOlympus America, Inc.
Decision Date1995-05-03
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OLYMPUS FD-5 HOT 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 1995-05-03 under 510(k) number K951445. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS FD-5 HOT BIOPSY FORCEPS?

OLYMPUS FD-5 HOT BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1995-05-03. The listed applicant is Olympus America, Inc.. The 510(k) number is K951445.

When did OLYMPUS FD-5 HOT BIOPSY FORCEPS receive FDA 510(k) clearance?

OLYMPUS FD-5 HOT BIOPSY FORCEPS received FDA 510(k) clearance on 1995-05-03, under 510(k) number K951445.

Who is the listed applicant for OLYMPUS FD-5 HOT 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 FD-5 HOT BIOPSY FORCEPS?

The FDA product code for OLYMPUS FD-5 HOT BIOPSY FORCEPS is KGE.

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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: KGE)

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.

K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems CorporationK242857ClearHemograsperFinemedix Co., Ltd.K231721Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd.K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm CorporationK210406Bipolar Coagulation ForecepsHangzhou AGS MedTech Co., Ltd.

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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