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FDA 510(k)

MULTI-BITE HOT BIOPSY FORCEPS

K-Number: K090796 · 2009-11-25

ApplicantEndo-Therapeutics, Inc.
Decision Date2009-11-25
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MULTI-BITE HOT BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Endo-Therapeutics, Inc.. It received FDA 510(k) clearance on 2009-11-25 under 510(k) number K090796. 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 MULTI-BITE HOT BIOPSY FORCEPS?

MULTI-BITE HOT BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 2009-11-25. The listed applicant is Endo-Therapeutics, Inc.. The 510(k) number is K090796.

When did MULTI-BITE HOT BIOPSY FORCEPS receive FDA 510(k) clearance?

MULTI-BITE HOT BIOPSY FORCEPS received FDA 510(k) clearance on 2009-11-25, under 510(k) number K090796.

Who is the listed applicant for MULTI-BITE HOT BIOPSY FORCEPS?

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

What is the FDA product code for MULTI-BITE HOT BIOPSY FORCEPS?

The FDA product code for MULTI-BITE HOT BIOPSY FORCEPS is KGE.

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Other records listing Endo-Therapeutics, 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.

K031026ETI BIPOLAR HEMOSTATIC PROBEK023603ENDO-GLIDE GUIDEWIREK012725TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIESK012977VARICES INJECTION NEEDLEK926549ENDOCATH ELECTROPHYSIOLOGY CATHETERK925392BIOPSY FORCEPS

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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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