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FDA 510(k)

SIS FISTULA PLUG

K-Number: K050337 · 2005-03-09

ApplicantCook Biotech, Inc.
Decision Date2005-03-09
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIS FISTULA PLUG is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech, Inc.. It received FDA 510(k) clearance on 2005-03-09 under 510(k) number K050337. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIS FISTULA PLUG?

SIS FISTULA PLUG is a medical device that received FDA 510(k) clearance on 2005-03-09. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K050337.

When did SIS FISTULA PLUG receive FDA 510(k) clearance?

SIS FISTULA PLUG received FDA 510(k) clearance on 2005-03-09, under 510(k) number K050337.

Who is the listed applicant for SIS FISTULA PLUG?

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

What is the FDA product code for SIS FISTULA PLUG?

The FDA product code for SIS FISTULA PLUG is FTM.

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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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