Cleared Traditional

REXLON, REXSIL

K161633 · Sm Eng Co., Ltd. · General & Plastic Surgery

Mar 2017

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K161633 is an FDA 510(k) clearance for the REXLON, REXSIL, a Suture, Nonabsorbable, Synthetic, Polyamide (Class II — Special Controls, product code GAR), submitted by Sm Eng Co., Ltd. (Sasang-Gu, KR). The FDA issued a Cleared decision on March 2, 2017, 262 days after receiving the submission on June 13, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5020.

Submission Details

510(k) Number	K161633 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2016
Decision Date	March 02, 2017
Days to Decision	262 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF