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FDA 510(k)

WILTEK POLYPECTOMY SNARE

K-Number: K894869 · 1989-12-21

ApplicantWiltek Medical, Inc.
Decision Date1989-12-21
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILTEK POLYPECTOMY SNARE 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 1989-12-21 under 510(k) number K894869. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILTEK POLYPECTOMY SNARE?

WILTEK POLYPECTOMY SNARE is a medical device that received FDA 510(k) clearance on 1989-12-21. The listed applicant is Wiltek Medical, Inc.. The 510(k) number is K894869.

When did WILTEK POLYPECTOMY SNARE receive FDA 510(k) clearance?

WILTEK POLYPECTOMY SNARE received FDA 510(k) clearance on 1989-12-21, under 510(k) number K894869.

Who is the listed applicant for WILTEK POLYPECTOMY SNARE?

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 POLYPECTOMY SNARE?

The FDA product code for WILTEK POLYPECTOMY SNARE is FDI.

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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.

K990231WILTEK HOT BIOPSY FORCEPSK922989WILTEK IRRIGAITON/ASPIRATION TUBE SETK930419WILTEK BIOPSY FORCEPSK914881WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERK914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETERK914131WILTEK ELECTROCAUTERY ADAPTOR

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Related Devices (Code: FDI)

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.

K251692Advanced Tissue Resection DeviceMicro-Tech (Nanjing) Co., Ltd.K221713Polypectomy SnareHangzhou AGS MedTech Co., Ltd.K220846CORE-SNAREIncore Co., Ltd.K220089Disposable Polyp SnareJiangsu Vedkang Medical Science and Technology Co., Ltd.K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid SnareYangzhou Fartley Medical Instrument Technology Co., Ltd.K213222Disposable Polypectomy SnareBeijing Zksk Technology 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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