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FDA 510(k)

COOK UROLOGICAL GRAFT

K-Number: K090688 · 2009-07-10

ApplicantCook Biotech, Inc.
Decision Date2009-07-10
Product CodePAG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOK UROLOGICAL GRAFT 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 2009-07-10 under 510(k) number K090688. The device is classified under product code PAG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK UROLOGICAL GRAFT?

COOK UROLOGICAL GRAFT is a medical device that received FDA 510(k) clearance on 2009-07-10. The listed applicant is Cook Biotech, Inc.. The 510(k) number is K090688.

When did COOK UROLOGICAL GRAFT receive FDA 510(k) clearance?

COOK UROLOGICAL GRAFT received FDA 510(k) clearance on 2009-07-10, under 510(k) number K090688.

Who is the listed applicant for COOK UROLOGICAL GRAFT?

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 COOK UROLOGICAL GRAFT?

The FDA product code for COOK UROLOGICAL GRAFT is PAG.

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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 CYLINDERK082682SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUGK082058DYNAMATRIXK073391SURGISIS BIODESIGN TISSUE GRAFT

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Related Devices (Code: PAG)

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.

K050445AMS COLLAGEN DERMAL MATRIXAmerican Medical Systems, Inc.K042949PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)C.R. Bard, Inc.K031295BARD INNERLACE BIOURETHRAL SUPPORT SYSTEMC.R. Bard, Inc.K030460MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXBrennen Medical, Inc.K020654STRATASIS SLING KITCook Biotech, Inc.K993459MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIXAdvanced Uroscience, Inc.

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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