K160623 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. This device is classified as 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 May 31, 2016, 88 days after receiving the submission on March 4, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5030.
| 510(k) Number | K160623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2016 |
| Decision Date | May 31, 2016 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAP - Suture, Nonabsorbable, Silk |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5030 |