FDA 510(k)

Biodesign Sling, Matrice de Chirurgie Plastique Biodesign, Plug de Fistule Anale Biodesign

Numéro K : K161221 · 2016-05-26

Date de décision2016-05-26

Code produitFTM

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal 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 2016-05-26 under 510(k) number K161221. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug?

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug is a medical device that received FDA 510(k) clearance on 2016-05-26. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K161221.

When did Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug receive FDA 510(k) clearance?

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug received FDA 510(k) clearance on 2016-05-26, under 510(k) number K161221.

Who is the listed applicant for Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal 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 Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug?

The FDA product code for Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug is FTM.

Essais cliniques associés

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Autres dossiers indiquant Cook Biotech Incorporated en tant que demandeur

K232646Biodesign Otologique Papillon Greffon (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologique Papillon Greffon (ENT-OTO-BFLY-0.6-0.9)K201000Biodesign Renforcement de Ligne d'Épingles K191696Biodesign Bouchon Anale de Design Biologique, Biodesign Bouchon Fistule, Biodesign Matrice de Chirurgie Plastique, Biodesign Greffon Tissulaire K171817Biodesign Greffe d'hernie diaphragmatique K162934Biodesign Greffe de Réparation d'Hernie Parastomale K170016Biodesign Plaque fistule

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Source officielle

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