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FDA 510(k)

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft

K-Number: K160869 · 2016-04-29

ApplicantCook Biotech Incorporated
Decision Date2016-04-29
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is a medical device manufactured by Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-04-29 under approval number K160869. 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 Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is a medical device that received FDA 510(k) clearance on 2016-04-29. It is manufactured by Cook Biotech Incorporated. The 510(k) number is K160869.

When was Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft approved by the FDA?

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft received FDA 510(k) clearance on 2016-04-29, under approval number K160869.

What company makes Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is manufactured by Cook Biotech Incorporated.

What is the FDA product code for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

The FDA product code for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is FTM.

Related Clinical Trials

NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT07368348 Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks RECRUITING NCT07608744 Alloplastic Graft vs Xenograft for Horizontal Alveolar Ridge Augmentation COMPLETED NCT06335628 Volumetric Dimensional Changes After Surgical Pontic Site Development Procedures With Connective Tissue Graft or Collagen Matrix RECRUITING NCT04503395 ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES RECRUITING NCT07316192 Pelashield™ PainGuard™ vs Restrata® in HS Surgery RECRUITING

Related PubMed Literature

PMID: 38822140 "The novel dura substitute: a revolutionary advancement in neurosurgery". Neurosurgical review (2024) PMID: 37343508 Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review. American journal of otolaryngology (2023) PMID: 28608618 Bench-to-bedside: Bridge-enhanced anterior cruciate ligament repair. Journal of orthopaedic research : official publication of the Orthopaedic Research Society (2017)

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 K162934Biodesign Parastomal Hernia Repair Graft K170016Biodesign Fistula Plug

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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 K153633Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited) K152206SurgiPure XD Reconstructive Tissue MatrixTissue Regenix Group Plc

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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