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FDA 510(k)

Biodesign Parastomal Hernia Repair Graft

K-Number: K162934 · 2017-07-10

ApplicantCook Biotech Incorporated
Decision Date2017-07-10
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biodesign Parastomal Hernia Repair Graft is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2017-07-10 under approval number K162934. 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 Biodesign Parastomal Hernia Repair Graft?

Biodesign Parastomal Hernia Repair Graft is a medical device that received FDA 510(k) clearance on 2017-07-10. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K162934.

When was Biodesign Parastomal Hernia Repair Graft approved by the FDA?

Biodesign Parastomal Hernia Repair Graft received FDA 510(k) clearance on 2017-07-10, under approval number K162934.

What company makes Biodesign Parastomal Hernia Repair Graft?

Biodesign Parastomal Hernia Repair Graft is manufactured by Cook Biotech Incorporated.

What is the FDA product code for Biodesign Parastomal Hernia Repair Graft?

The FDA product code for Biodesign Parastomal Hernia Repair Graft is FTM.

Related Clinical Trials

NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07368348 Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks RECRUITING NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT07065760 University of Utah PS-IDE: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms RECRUITING NCT06658730 Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance RECRUITING NCT06029660 AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion RECRUITING

Related PubMed Literature

PMID: 41200076 Experimental methodology used for testing RSC advances (2025)

Other Devices by Cook Biotech Incorporated

K162741AxoGuard Nerve Connector K160136Flowable Wound Matrix K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug K161000Biodesign Otologic Repair Graft K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft K170016Biodesign Fistula Plug

View all 13 devices →

Related Devices (Code: FTM)

K162461Endoform Plastics and Reconstructive MatrixAroa Biosurgery (Formerly Mesynthes Limited) K162554Gentrix Surgical MatrixAcell, Inc. K160181COLORADO THERAPEUTICS XENOGRAFT IMPLANTColorado Therapeutics, LLC K161221Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula PlugCook Biotech Incorporated K160869Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair GraftCook Biotech Incorporated K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)

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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