K252644
- 510(k) number
- K252644
- Device name
- PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture
- Applicant
- M/s. Meril Endo Surgery Private Limited. IN
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2025-09-23
- Date received
- 2025-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K252644.pdf
Official FDA record: K252644
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.