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FDA 510(k)

COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K

K-Number: K111495 · 2011-07-19

ApplicantWilson-Cook Medical, Inc.
Decision Date2011-07-19
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K 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 2011-07-19 under 510(k) number K111495. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K?

COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K is a medical device that received FDA 510(k) clearance on 2011-07-19. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K111495.

When did COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K receive FDA 510(k) clearance?

COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K received FDA 510(k) clearance on 2011-07-19, under 510(k) number K111495.

Who is the listed applicant for COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K?

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 COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K?

The FDA product code for COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K is FBK.

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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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