Henry Schein 5700148
Henry Schein 5700148 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 00304040019832), 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 | Number00304040019832 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK073053 | Date15 Nov 2007 | StatusActive |
Official records
- AccessGUDID record 00304040019832
- FDA 510(k) database K073053
Across registries
- FDA 510(k) K073053 decided 15 Nov 2007 Active
- FDA GUDID UDI-DI 00304040019832 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K073053
- Listed FDA GUDID 00304040019832
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Henry Schein
- Generic name
- Colposcope
- Model / Ref / Catalog
- 5700148
- Primary DI / UDI-DI
- 00304040019832
- 510(k) Number
- FDA product code
- HEX
- GMDN term
- Colposcope
- Device class
- Class II
- Regulation number
- 884.1630
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HEX (COLPOSCOPE (AND COLPOMICROSCOPE)).
- MICROSTAR Colposcope R00 U1C100T1 by Ecleris
- Colposcope System by Xuzhou Kernel Medical Equipment Co., Ltd.
- ACCUSCOPE(TM) & ACCUSCOPE II(TM) by Vineland Medical Products, Inc.
- LEICA COLPOSCOPE by Leica Microscopy Systems, Ltd.
- DFV CPG COLPOSCOPE by D.F. Vasconcellos S.A.
- KRYMED SYSTEM 4001 TILT SCOPE by Cryomedics, Inc.
- MEDSCOPE by All-Pro Imaging Corp.
- MICROSTAR Colposcope R00 U1C100W3 by Ecleris
- PHOTOSTAR V-8 by Wallach Surgical Devices, Inc.
- DYSIS by Forth Photonics Hellas SA