Cleared Abbreviated

Biotex

K180992 · Purgo Biologics, Inc. · General & Plastic Surgery

Jul 2019

Decision

456d

Days

Class 2

Risk

About This 510(k) Submission

K180992 is an FDA 510(k) clearance for the Biotex, a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II — Special Controls, product code NBY), submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on July 16, 2019, 456 days after receiving the submission on April 16, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5035.

Submission Details

510(k) Number	K180992 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2018
Decision Date	July 16, 2019
Days to Decision	456 days
Submission Type	Abbreviated
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	NBY — Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5035