Wallach 906043-Sp-5
Wallach 906043-Sp-5 is a colposcope (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by CooperSurgical, Inc., cleared under FDA 510(k) K853389 on 19 Nov 1985 and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 00888937013689), 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 | Number00888937013689 | Date18 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK853389 | Date19 Nov 1985 | StatusActive |
Official records
- AccessGUDID record 00888937013689
- FDA 510(k) database K853389
Across registries
- FDA 510(k) K853389 decided 19 Nov 1985 Active
- FDA GUDID UDI-DI 00888937013689 listed 18 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K853389
- Listed FDA GUDID 00888937013689
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Wallach
- Generic name
- Colposcope
- Model / reference
- 906043-SP-5
- Primary DI / UDI-DI
- 00888937013689
- 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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