Jelco G1790
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number15019517053104 | Date6 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK923127 | Date29 Apr 1993 | StatusActive |
Recalls
-
- Terminated Z-2670-2017
Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro needles, Smiths Medical part numbers EL 1915 and SB5021.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Jelco
- Generic name
- Hypodermic needle, single-use
- Model / reference
- G1790
- Primary DI / UDI-DI
- 15019517053104
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Hypodermic needle, single-use
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
Other devices from ICU Medical, Inc.
Properties
Other properties (10)
- Supplied sterile: No
- Sterilise before use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No