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FDA 510(k)

Instinct Plus Endoscopic Clipping Device

K-Number: K212323 · 2021-08-25

ApplicantWilson-Cook Medical, Inc.
Decision Date2021-08-25
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 Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K212323. 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 2021-08-25. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K212323.

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

Instinct Plus Endoscopic Clipping Device received FDA 510(k) clearance on 2021-08-25, under 510(k) number K212323.

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

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 Plus Endoscopic Clipping Device?

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

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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.

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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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