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FDA 510(k)

ENDOCHOICE HOT BIOPSY FORCEPS

K-Number: K131991 · 2013-10-15

ApplicantEndochoice, Inc.
Decision Date2013-10-15
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOCHOICE HOT BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2013-10-15 under 510(k) number K131991. 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 ENDOCHOICE HOT BIOPSY FORCEPS?

ENDOCHOICE HOT BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 2013-10-15. The listed applicant is Endochoice, Inc.. The 510(k) number is K131991.

When did ENDOCHOICE HOT BIOPSY FORCEPS receive FDA 510(k) clearance?

ENDOCHOICE HOT BIOPSY FORCEPS received FDA 510(k) clearance on 2013-10-15, under 510(k) number K131991.

Who is the listed applicant for ENDOCHOICE HOT BIOPSY FORCEPS?

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

What is the FDA product code for ENDOCHOICE HOT BIOPSY FORCEPS?

The FDA product code for ENDOCHOICE HOT BIOPSY FORCEPS is KGE.

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Other records listing Endochoice, Inc. as applicant

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K160275Fuse Endoscopic System with FuseBox ProcessorK161482EndoChoice Water Bottle Cap Irrigation SystemK161167Seal Single-Use Biopsy ValveK160403SmartStart Air/Water and Suction ValvesK153588EndoChoice Water Bottle Cap SystemK151475EndoChoice Select Injection Needle

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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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