K232246 is an FDA 510(k) clearance for the 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture. This device is classified as a Suture, Surgical, Absorbable, Polydioxanone (Class II - Special Controls, product code NEW).
Submitted by M/s. Meril Endo Surgery Private Limited. (Vapi, IN). The FDA issued a Cleared decision on April 25, 2024, 272 days after receiving the submission on July 28, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K232246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2023 |
| Decision Date | April 25, 2024 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEW - Suture, Surgical, Absorbable, Polydioxanone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4840 |