Cleared Special

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

K172149 · M/s. Meril Endo Surgery Private Limited. · General & Plastic Surgery

Oct 2017

Decision

95d

Days

Class 2

Risk

About This 510(k) Submission

K172149 is an FDA 510(k) clearance for the FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture, a Suture, Nonabsorbable, Silk (Class II — Special Controls, product code GAP), submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on October 20, 2017, 95 days after receiving the submission on July 17, 2017. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5030.

Submission Details

510(k) Number	K172149 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 17, 2017
Decision Date	October 20, 2017
Days to Decision	95 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF