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FDA 510(k)

WILTEK HOT BIOPSY FORCEPS

K-Number: K990231 · 1999-04-13

ApplicantWiltek Medical, Inc.
Decision Date1999-04-13
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILTEK HOT BIOPSY FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Wiltek Medical, Inc.. It received FDA 510(k) clearance on 1999-04-13 under 510(k) number K990231. 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 WILTEK HOT BIOPSY FORCEPS?

WILTEK HOT BIOPSY FORCEPS is a medical device that received FDA 510(k) clearance on 1999-04-13. The listed applicant is Wiltek Medical, Inc.. The 510(k) number is K990231.

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

WILTEK HOT BIOPSY FORCEPS received FDA 510(k) clearance on 1999-04-13, under 510(k) number K990231.

Who is the listed applicant for WILTEK HOT BIOPSY FORCEPS?

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

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

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

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Other records listing Wiltek Medical, 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.

K922989WILTEK IRRIGAITON/ASPIRATION TUBE SETK930419WILTEK BIOPSY FORCEPSK914881WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERK914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETERK914131WILTEK ELECTROCAUTERY ADAPTORK914132WILTEK ELECTROCAUTERY ACTIVE CORD

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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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