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FDA 510(k)

INSTINCT ENDOSCOPIC HEMOCLIP

K-Number: K132809 · 2013-10-25

ApplicantWilson-Cook Medical, Inc.
Decision Date2013-10-25
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INSTINCT ENDOSCOPIC HEMOCLIP is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2013-10-25 under 510(k) number K132809. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTINCT ENDOSCOPIC HEMOCLIP?

INSTINCT ENDOSCOPIC HEMOCLIP is a medical device that received FDA 510(k) clearance on 2013-10-25. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K132809.

When did INSTINCT ENDOSCOPIC HEMOCLIP receive FDA 510(k) clearance?

INSTINCT ENDOSCOPIC HEMOCLIP received FDA 510(k) clearance on 2013-10-25, under 510(k) number K132809.

Who is the listed applicant for INSTINCT ENDOSCOPIC HEMOCLIP?

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

What is the FDA product code for INSTINCT ENDOSCOPIC HEMOCLIP?

The FDA product code for INSTINCT ENDOSCOPIC HEMOCLIP is PKL.

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Other records listing Wilson-Cook Medical, Inc. as applicant

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Related Devices (Code: PKL)

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.

K253481colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72)Ovesco Endoscopy AGK254069Hemoclip (511 series, 543 series)Hangzhou AGS MedTech Co., Ltd.K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734Taurus ClipTaurus EndoscopyK251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG

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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