Cleared Traditional

K171817 - Biodesign Diaphragmatic Hernia Graft
(FDA 510(k) Clearance)

K171817 · Cook Biotech Incorporated · General & Plastic Surgery
Mar 2018
Decision
267d
Days
Class 2
Risk

K171817 is an FDA 510(k) clearance for the Biodesign Diaphragmatic Hernia Graft, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Cook Biotech Incorporated (West Lafayetta, US). The FDA issued a Cleared decision on March 13, 2018, 267 days after receiving the submission on June 19, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K171817 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2017
Decision Date March 13, 2018
Days to Decision 267 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTM — Mesh, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300