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FDA 510(k)

Biodesign Fistula Plug

K-Number: K170016 · 2017-06-21

ApplicantCook Biotech Incorporated
Decision Date2017-06-21
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biodesign Fistula Plug 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 2017-06-21 under 510(k) number K170016. 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 Fistula Plug?

Biodesign Fistula Plug is a medical device that received FDA 510(k) clearance on 2017-06-21. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K170016.

When did Biodesign Fistula Plug receive FDA 510(k) clearance?

Biodesign Fistula Plug received FDA 510(k) clearance on 2017-06-21, under 510(k) number K170016.

Who is the listed applicant for Biodesign Fistula Plug?

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 Fistula Plug?

The FDA product code for Biodesign Fistula Plug is FTM.

Other records listing Cook Biotech Incorporated 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.

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 ReinforcementK191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftK171817Biodesign Diaphragmatic Hernia GraftK162934Biodesign Parastomal Hernia Repair GraftK170945Biodesign Staple Line Reinforcement

View all 13 devices →

Related Devices (Code: FTM)

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.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform 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.

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