Jelco 4244
Jelco 4244 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K946289 on 10 Jul 1995 and listed in FDA GUDID since 17 Jan 2017 (UDI-DI 10351688044983), active as of 23 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 | Number10351688044983 | Date17 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK946289 | Date10 Jul 1995 | StatusActive |
Official records
- AccessGUDID record 10351688044983
- FDA 510(k) database K946289
Across registries
- FDA 510(k) K946289 decided 10 Jul 1995 Active
- FDA GUDID UDI-DI 10351688044983 listed 17 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K946289
- Listed FDA GUDID 10351688044983
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Jelco
- Generic name
- Needle guard
- Model / reference
- 4244
- Primary DI / UDI-DI
- 10351688044983
- 510(k) Number
- FDA product code
- FMI
- GMDN term
- Needle guard
- Device class
- Class II
- Regulation number
- 880.5570
- GUDID distribution status
- In Commercial Distribution
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