Cleared Traditional

WEGO-PTFE

K170842 · Foosin Medical Supplies Inc., Ltd. · General & Plastic Surgery

Jul 2017

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K170842 is an FDA 510(k) clearance for the WEGO-PTFE, a Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (Class II — Special Controls, product code NBY), submitted by Foosin Medical Supplies Inc., Ltd. (Weihai, CN). The FDA issued a Cleared decision on July 31, 2017, 132 days after receiving the submission on March 21, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5035.

Submission Details

510(k) Number	K170842 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2017
Decision Date	July 31, 2017
Days to Decision	132 days
Submission Type	Traditional
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