Ul-DU500SER
by Zimmer Orthopaedic Surgical Products
Ul-DU500SER is a Class II device made by Zimmer Orthopaedic Surgical Products, cleared under FDA 510(k) K133786 on 21 Mar 2014 (1 earlier submission) and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00889024465848), active as of 22 Oct 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 | Number00889024465848 | Date22 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133786 | Date21 Mar 2014 | StatusActive |
Official records
- AccessGUDID record 00889024465848
- FDA 510(k) database K133786
- FDA 510(k) database K123188
Across registries
- FDA 510(k) K133786 decided 21 Mar 2014 Active
- FDA GUDID UDI-DI 00889024465848 listed 22 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K123188
- Cleared FDA 510(k) K133786
- Listed FDA GUDID 00889024465848
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Surgical fluid/smoke waste management system suction unit
- Model / Ref / Catalog
- UL-DU500SER
- Primary DI / UDI-DI
- 00889024465848
- FDA product code
- JCX
- GMDN term
- Surgical fluid/smoke waste management system suction unit
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
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