Cleared Traditional

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

K191696 · Cook Biotech Incorporated · General & Plastic Surgery
Dec 2019
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K191696 is an FDA 510(k) clearance for the Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft, a Mesh, Surgical, Collagen, Fistula (Class II — Special Controls, product code OXN), submitted by Cook Biotech Incorporated (West Lafayetta, US). The FDA issued a Cleared decision on December 27, 2019, 185 days after receiving the submission on June 25, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K191696 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2019
Decision Date December 27, 2019
Days to Decision 185 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code OXN — Mesh, Surgical, Collagen, Fistula
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition For Reinforcement Of Soft Tissue Where Weakness Exists During The Repair Of Fistulas.