510(k) K252820
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus) by
Internacional Farmacéutica S.A DE C.V
— Product Code GAM
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2025
- Date Received
- September 4, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Device Class
- Class II
- Regulation Number
- 878.4493
- Review Panel
- SU
- Submission Type