Chalgren 293-2-48TP
Chalgren 293-2-48TP is a Class II device made by Chalgren Enterprises, Inc., cleared under FDA 510(k) K953356 on 22 Jan 1996 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00816020020719), 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 | Number00816020020719 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK953356 | Date22 Jan 1996 | StatusActive |
Official records
- AccessGUDID record 00816020020719
- FDA 510(k) database K953356
Across registries
- FDA 510(k) K953356 decided 22 Jan 1996 Active
- FDA GUDID UDI-DI 00816020020719 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K953356
- Listed FDA GUDID 00816020020719
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Chalgren
- Generic name
- Analytical non-scalp cutaneous lead
- Model / Ref / Catalog
- 293-2-48TP
- Primary DI / UDI-DI
- 00816020020719
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Analytical non-scalp cutaneous lead
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 48 Inch
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