PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
FDA 510(k) clearance K252820 · decided 2025-10-03
Clearance details
- 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
- Decision
- Substantially Equivalent
- Date received
- 2025-09-04
- Decision date
- 2025-10-03
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lerma, MX
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.