Chalgren 264-9P-36STP
Chalgren 264-9P-36STP is a Class II device made by Chalgren Enterprises, Inc., cleared under FDA 510(k) K952908 on 6 Dec 1995 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00816020020481), 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 | Number00816020020481 | Date9 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK952908 | Date6 Dec 1995 | StatusActive |
Official records
- AccessGUDID record 00816020020481
- FDA 510(k) database K952908
Across registries
- FDA 510(k) K952908 decided 6 Dec 1995 Active
- FDA GUDID UDI-DI 00816020020481 listed 9 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K952908
- Listed FDA GUDID 00816020020481
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- Withdrawn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
- 264-9P-36STP
- Primary DI / UDI-DI
- 00816020020481
- 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 — 36 Inch
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