K243897 is an FDA 510(k) clearance for the PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture. This device is classified as a Suture, Surgical, Absorbable, Polydioxanone (Class II - Special Controls, product code NEW).
Submitted by Ethicon, Inc. (Raritan, US). The FDA issued a Cleared decision on November 12, 2025, 328 days after receiving the submission on December 19, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4840.
| 510(k) Number | K243897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2024 |
| Decision Date | November 12, 2025 |
| Days to Decision | 328 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 |