Identity
- Trade Name
- FILAPRON FDA UDI
- Generic Name
- Poliglecaprone suture FDA UDI
- Device Name
- Monofilament Poly (glycolide-co-caprolactone) Surgical Suture FDA UDI
- Model / Reference
- PCL50490U FDA UDI
- Description
- Monofilament Poly (glycolide-co-caprolactone) Surgical Suture FDA UDI
Identifiers
- Catalog Number
- PCL50490U FDA UDI
- Primary DI / UDI-DI
- 18904255219929 FDA UDI
- 510(k) Number
- K172659 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Poliglecaprone suture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Poliglecaprone suture
Filapron by Meril Endo Surgery Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Poliglecaprone suture.
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Cleared under the same submission
K172659 also covers:
- FILAPRON — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAPRON — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAPRON — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAPRON — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAPRON — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAPRON — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAXYN — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAXYN — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAXYN — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAXYN — MERIL ENDO SURGERY PRIVATE LIMITED
- FILAXYN — MERIL ENDO SURGERY PRIVATE LIMITED
- MEGASORB — MERIL ENDO SURGERY PRIVATE LIMITED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Meril Endo Surgery Private Limited
Sources (1)
- FDA UDI 3607ba3f-2d38-4b6e-899a-3157e7195636 37 fields · synced May 31, 2026