Causse / Polycel® 1112197
Causse / Polycel® 1112197 is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K810707 on 16 Jun 1981 and listed in FDA GUDID since 7 Nov 2021 (UDI-DI 00763000034801), active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00763000034801 | Date7 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK810707 | Date16 Jun 1981 | StatusActive |
Official records
- AccessGUDID record 00763000034801
- FDA 510(k) database K810707
Across registries
- FDA 510(k) K810707 decided 16 Jun 1981 Active
- FDA GUDID UDI-DI 00763000034801 listed 7 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K810707
- Listed FDA GUDID 00763000034801
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Causse / Polycel®
- Generic name
- Ossicular prosthesis, partial
- Model / reference
- 1112197
- Primary DI / UDI-DI
- 00763000034801
- 510(k) Number
- FDA product code
- ETA
- GMDN term
- Ossicular prosthesis, partial
- Device class
- Class II
- Regulation number
- 874.3495
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Length — 4.75 Millimeter