K232246
- 510(k) number
- K232246
- Device name
- 1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
- Applicant
- M/s. Meril Endo Surgery Private Limited. IN
- Product code
- NEW — Suture, Surgical, Absorbable, Polydioxanone
- Decision date
- 2024-04-25
- Date received
- 2023-07-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K232246.pdf
Official FDA record: K232246
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.