FDA 510(k)
FDA class 2
Substantially Equivalent
🇲🇽 Mexico
PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
K Number: K252820
·
Decision Oct 3, 2025
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
1
Review Days
29
Basic Information
- Device Name
- PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Odysseus)
- K Number
- K252820
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Internacional Farmacéutica S.A DE C.V
- Date Received
- September 4, 2025
- Decision Date
- October 3, 2025
- Product Code
- GAM
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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