FDA 510(k)

Biodesign Bouchon Anale de Design Biologique, Biodesign Bouchon Fistule, Biodesign Matrice de Chirurgie Plastique, Biodesign Greffon Tissulaire

Numéro K : K191696 · 2019-12-27

Date de décision2019-12-27

Code produitOXN

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue 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 2019-12-27 under 510(k) number K191696. The device is classified under product code OXN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K191696.

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

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft received FDA 510(k) clearance on 2019-12-27, under 510(k) number K191696.

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

The FDA product code for Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft is OXN.

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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 K171817Biodesign Greffe d'hernie diaphragmatique K162934Biodesign Greffe de Réparation d'Hernie Parastomale K170016Biodesign Plaque fistule K170945Biodesign Renforcement de Ligne d'Épingles

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Source officielle

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