Identity
- Trade Name
- ProSup FDA UDI
- Generic Name
- Pelvic organ prolapse surgical mesh, synthetic polymer FDA UDI
- Device Name
- Pelvic Floor Repair Mesh,Polyester,Height: 4.5 cm;2.5 cm;3 cm FDA UDI
- Model / Reference
- TECLGK01 FDA UDI
- Description
- Pelvic Floor Repair Mesh,Polyester,Height: 4.5 cm;2.5 cm;3 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521177611 FDA UDI
- 510(k) Number
- K982532 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Pelvic organ prolapse surgical mesh, synthetic polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Dimensions & Sizes
- Size
- Width — 15 Centimeter FDA UDI
Category: Pelvic organ prolapse surgical mesh, synthetic polymer
ProSup by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pelvic organ prolapse surgical mesh, synthetic polymer.
- Upsylon™ Y Mesh Kit — Boston Scientific · Class II
- GYNECARE GYNEMESH — Ethicon Inc. · Class II
- Polyform™ — Boston Scientific · Class II
- Coloplast — Coloplast A/S · Class II
- Colpassist — Boston Scientific · Class I
- Restorelle — Coloplast A/S · Class II
- Restorelle — Coloplast A/S · Class II
- GYNECARE GYNEMESH — Ethicon Inc. · Class II
Cleared under the same submission
K982532 also covers:
- ProSup — Covidien LP
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
- Parietex — SOFRADIM PRODUCTION
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI c625d419-6f04-4cb7-a6ef-6a30754b38d0 36 fields · synced May 29, 2026