MICROSCOPE Colposcope R00
MICROSCOPE Colposcope R00 (HC200A) is a colposcope (FDA Class II; FDA product code HEX, Colposcope (And Colpomicroscope)) made by Ecleris, cleared under FDA 510(k) K100595 on 9 Jul 2010 and listed in FDA GUDID since 27 Nov 2024 (UDI-DI B366HC200AR00), 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 | NumberB366HC200AR00 | Date27 Nov 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100595 | Date9 Jul 2010 | StatusActive |
Official records
- FDA 510(k) database K100595
Across registries
- FDA 510(k) K100595 decided 9 Jul 2010 Active
- FDA GUDID UDI-DI B366HC200AR00 listed 27 Nov 2024 Listed
Timeline
- Cleared FDA 510(k) K100595
- Listed FDA GUDID B366HC200AR00
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MICROSCOPE Colposcope
- Generic name
- Colposcope
- Model / Ref / Catalog
- R00, HC200A
- Primary DI / UDI-DI
- B366HC200AR00
- 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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