K233265 is an FDA 510(k) clearance for the Monotime and Optime R. This device is classified as a Suture, Absorbable, Synthetic, Polyglycolic Acid (Class II - Special Controls, product code GAM).
Submitted by Peters Surgical (Plymouth, US). The FDA issued a Cleared decision on October 11, 2024, 378 days after receiving the submission on September 29, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4493.
| 510(k) Number | K233265 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | October 11, 2024 |
| Days to Decision | 378 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAM - Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4493 |