Henry Schein 5700145
Henry Schein 5700145 is a colposcope (FDA Class II; FDA product code HEX, Colposcope (and Colpomicroscope)) made by Henry Schein, Inc., cleared under FDA 510(k) K073053 on 15 Nov 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00304040019801), 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 | Number00304040019801 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK073053 | Date15 Nov 2007 | StatusActive |
Official records
- AccessGUDID record 00304040019801
- FDA 510(k) database K073053
Across registries
- FDA 510(k) K073053 decided 15 Nov 2007 Active
- FDA GUDID UDI-DI 00304040019801 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K073053
- Listed FDA GUDID 00304040019801
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Henry Schein
- Generic name
- Colposcope
- Model / Ref / Catalog
- 5700145
- Description
- Colposcope Articulating Arm Trinoc 3 leg , LED.
- Primary DI / UDI-DI
- 00304040019801
- 510(k) Number
- FDA product code
- HEX
- GMDN term
- Colposcope
- Device class
- Class II
- Regulation number
- 884.1630
- GUDID distribution status
- In Commercial Distribution
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