FDA 510(k)

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

K-Number: K160869 · 2016-04-29

Decision Date2016-04-29

Product CodeFTM

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2016-04-29 under 510(k) 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. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K160869.

When did Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft receive FDA 510(k) clearance?

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

Who is the listed applicant for Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft?

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

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

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.

NCT06464705To Investigate the Effect of PEMF for Pateitns After Anterior Cruciate Ligament Reconstruction With Hamstring AutograftRECRUITING NCT07529340Study of Hyaluronic Acid Used With Gum Surgery to Treat Gum Recession in AdultsNOT_YET_RECRUITING NCT07765862A PROSPECTIVE, RANDOMIZED, TWO-ARM, CONTROLLED, SINGLE-BLIND, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ARTIFIX® DURAL REPAIR SEALANT GRAFT IN CRANIAL AND SPINE SURGERY (NEOFIX STUDY)NOT_YET_RECRUITING NCT07768553A Trial of Absorbable Medical Adhesive for Prevention of CSF LeakCOMPLETED

Other records listing Cook Biotech Incorporated as applicant

K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)K201000Biodesign Staple Line Reinforcement K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft K171817Biodesign Diaphragmatic Hernia Graft K162934Biodesign Parastomal Hernia Repair Graft K170016Biodesign Fistula Plug

View all 13 devices →

Related Devices (Code: FTM)

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific K250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, 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.