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FDA 510(k)

Instinct Plus Endoscopic Clipping Device

K-Number: K192697 · 2020-03-05

ApplicantCook Endoscopy
Decision Date2020-03-05
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Instinct Plus Endoscopic Clipping Device is the device name listed in this FDA 510(k) record. The listed applicant is Cook Endoscopy. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K192697. 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 Plus Endoscopic Clipping Device?

Instinct Plus Endoscopic Clipping Device is a medical device that received FDA 510(k) clearance on 2020-03-05. The listed applicant is Cook Endoscopy. The 510(k) number is K192697.

When did Instinct Plus Endoscopic Clipping Device receive FDA 510(k) clearance?

Instinct Plus Endoscopic Clipping Device received FDA 510(k) clearance on 2020-03-05, under 510(k) number K192697.

Who is the listed applicant for Instinct Plus Endoscopic Clipping Device?

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

What is the FDA product code for Instinct Plus Endoscopic Clipping Device?

The FDA product code for Instinct Plus Endoscopic Clipping Device is PKL.

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.

K254069Hemoclip (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 AGK252271HemoclipHangzhou 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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