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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 a medical device manufactured by Cook Endoscopy. It received FDA 510(k) clearance on 2020-03-05 under approval 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. It is manufactured by Cook Endoscopy. The 510(k) number is K192697.

When was Instinct Plus Endoscopic Clipping Device approved by the FDA?

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

What company makes Instinct Plus Endoscopic Clipping Device?

Instinct Plus Endoscopic Clipping Device is manufactured by Cook Endoscopy.

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

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

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Related PubMed Literature

PMID: 28292410 The Regulatory Perspectives on Endoscopic Devices for Obesity. Gastrointestinal endoscopy clinics of North America (2017)

Related Devices (Code: PKL)

K153550FTRD System SetOvesco Endoscopy AG K170867FTRD System SetOvesco Endoscopy AG K161463SureClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. K182556SureClip Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. K180325Single Use MultiClip DeviceMicro-Tech (Nanjing) Co., Ltd. K172727HemoclipHangzhou 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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