Luer Lock Set, Single Lumen LL0002
Luer Lock Set, Single Lumen LL0002 is a hysteroscopic irrigation/insufflation system (FDA Class II) made by Thermedx, LLC, cleared under FDA 510(k) K133799 on 20 Jun 2014 (1 earlier submission) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00860936000334), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00860936000334 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK133799 | Date20 Jun 2014 | StatusActive |
Official records
- AccessGUDID record 00860936000334
- FDA 510(k) database K133799
- FDA 510(k) database K091939
Across registries
- FDA 510(k) K133799 decided 20 Jun 2014 Active
- FDA GUDID UDI-DI 00860936000334 listed 23 Sep 2016 Listed
Recalls
-
- Terminated Z-1463-2015
To correct software bugs that could affect the ability to accurately measure fluid deficit.
-
- Terminated Z-2555-2014
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.
Timeline
- Cleared FDA 510(k) K091939
- Recall initiated FDA recalls Z-2555-2014
- Cleared FDA 510(k) K133799
- Recall initiated FDA recalls Z-1463-2015
- Listed FDA GUDID 00860936000334
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Luer Lock Set, Single Lumen
- Generic name
- Hysteroscopic irrigation/insufflation system
- Model / reference
- LL0002
- Primary DI / UDI-DI
- 00860936000334
- FDA product code
- HRX, LGZ, HIG
- GMDN term
- Hysteroscopic irrigation/insufflation system
- Device class
- Class II
- Regulation number
- 888.1100, 880.5725, 884.1700
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Size
- Pressure — 250 millibar
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