K243897
- 510(k) number
- K243897
- Device name
- PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture
- Applicant
- ETHICON, Inc. NJ · US
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2025-11-12
- Date received
- 2024-12-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243897.pdf
Official FDA record: K243897
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.