Chalgren 110-737
Chalgren 110-737 is a Class II device made by Chalgren Enterprises, Inc., cleared under FDA 510(k) K912283 on 16 Mar 1992 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00816020020054), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00816020020054 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK912283 | Date16 Mar 1992 | StatusActive |
Official records
- AccessGUDID record 00816020020054
- FDA 510(k) database K912283
Across registries
- FDA 510(k) K912283 decided 16 Mar 1992 Active
- FDA GUDID UDI-DI 00816020020054 listed 9 Sep 2016 Listed
Recalls
-
- Terminated Z-2446-2010
Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.
Timeline
- Cleared FDA 510(k) K912283
- Recall initiated FDA recalls Z-2446-2010
- Listed FDA GUDID 00816020020054
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Chalgren
- Generic name
- Electromyographic needle electrode, single-use
- Model / Ref / Catalog
- 110-737
- Primary DI / UDI-DI
- 00816020020054
- 510(k) Number
- FDA product code
- IKT
- GMDN term
- Electromyographic needle electrode, single-use
- Device class
- Class II
- Regulation number
- 890.1385
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
- Size
- Needle Gauge — 27 Gauge
Similar devices in this category
Other devices filed under Electromyographic needle electrode, single-use.