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FDA 510(k)

SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG

K-Number: K082682 · 2009-02-27

ApplicantCook Biotech, Inc.
Decision Date2009-02-27
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGISIS BIODESIGN ENTEROCUTANEOUS 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 2009-02-27 under 510(k) number K082682. 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 SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG?

SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K082682.

When did SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG receive FDA 510(k) clearance?

SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG received FDA 510(k) clearance on 2009-02-27, under 510(k) number K082682.

Who is the listed applicant for SURGISIS BIODESIGN ENTEROCUTANEOUS 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 SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG?

The FDA product code for SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG is FTM.

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Other records listing Cook Biotech, Inc. as applicant

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.

K131015BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFTK111695HYBRID GRAFTK110402BIODESIGN NIPPLE RECONSTRUCTION CYLINDERK090688COOK UROLOGICAL GRAFTK082058DYNAMATRIXK073391SURGISIS BIODESIGN TISSUE GRAFT

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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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