7153
7153 is a Class II device made by PENTAX of America Inc., cleared under FDA 510(k) K093792 on 18 Mar 2010 and listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333231096), active as of 8 Nov 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 | Number04961333231096 | Date7 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093792 | Date18 Mar 2010 | StatusActive |
Official records
- AccessGUDID record 04961333231096
- FDA 510(k) database K093792
Across registries
- FDA 510(k) K093792 decided 18 Mar 2010 Active
- FDA GUDID UDI-DI 04961333231096 listed 7 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K093792
- Listed FDA GUDID 04961333231096
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Endoscopic light source unit, line-powered
- Model / reference
- 7153
- Primary DI / UDI-DI
- 04961333231096
- 510(k) Number
- FDA product code
- FCW
- GMDN term
- Endoscopic light source unit, line-powered
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
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