K252820
- 510(k) number
- K252820
- Device name
- PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
- Applicant
- Internacional Farmacéutica S.A DE C.V MX
- Product code
- GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid
- Decision date
- 2025-10-03
- Date received
- 2025-09-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252820.pdf
Official FDA record: K252820
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.