K150717 is an FDA 510(k) clearance for the Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron. This device is classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II - Special Controls, product code GAM).
Submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on October 14, 2015, 209 days after receiving the submission on March 19, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K150717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2015 |
| Decision Date | October 14, 2015 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GAM - Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4493 |