Fms 287345
Fms 287345 is a Class II device made by DePuy Mitek, Inc., cleared under FDA 510(k) K954465 on 9 Nov 1995 and listed in FDA GUDID since 17 Mar 2017 (UDI-DI 10886705000388), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10886705000388 | Date17 Mar 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK954465 | Date9 Nov 1995 | StatusActive |
Official records
- AccessGUDID record 10886705000388
- FDA 510(k) database K954465
Across registries
- FDA 510(k) K954465 decided 9 Nov 1995 Active
- FDA GUDID UDI-DI 10886705000388 listed 17 Mar 2017 Listed
Recalls
-
- Terminated Z-0658-2016
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
-
- Terminated Z-0192-2014
Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
Timeline
- Cleared FDA 510(k) K954465
- Recall initiated FDA recalls Z-0192-2014
- Recall initiated FDA recalls Z-0658-2016
- Listed FDA GUDID 10886705000388
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Fms
- Generic name
- Arthroscopic shaver system blade, single-use
- Model / Ref / Catalog
- 287345
- Primary DI / UDI-DI
- 10886705000388
- 510(k) Number
- FDA product code
- HRX
- GMDN term
- Arthroscopic shaver system blade, single-use
- Device class
- Class II
- Regulation number
- 888.1100
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Arthroscopic shaver system blade, single-use.