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FDA 510(k)

Biodesign Staple Line Reinforcement

K-Number: K201000 · 2020-07-13

ApplicantCook Biotech Incorporated
Decision Date2020-07-13
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biodesign Staple Line Reinforcement 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 2020-07-13 under 510(k) number K201000. 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 Staple Line Reinforcement?

Biodesign Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2020-07-13. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K201000.

When did Biodesign Staple Line Reinforcement receive FDA 510(k) clearance?

Biodesign Staple Line Reinforcement received FDA 510(k) clearance on 2020-07-13, under 510(k) number K201000.

Who is the listed applicant for Biodesign Staple Line Reinforcement?

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 Staple Line Reinforcement?

The FDA product code for Biodesign Staple Line Reinforcement is FTM.

Related Clinical Trials

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NCT07339020Cyanoacrylate Versus Omentum for Staple-Line Reinforcement in Sleeve GastrectomyCOMPLETED

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)K191696Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue GraftK171817Biodesign Diaphragmatic Hernia GraftK162934Biodesign Parastomal Hernia Repair GraftK170016Biodesign Fistula PlugK170945Biodesign Staple Line Reinforcement

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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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