ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
FDA 510(k) clearance K190744 · decided 2019-08-29
Clearance details
- K-number
- K190744
- Device name
- ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A)
- Applicant
- Olympus Winter & Ibe GmbH
- Decision
- Substantially Equivalent
- Date received
- 2019-03-22
- Decision date
- 2019-08-29
- Days to decision
- 160 days
- Clearance type
- Special
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Hamburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a vi recall (Z-0697-2024) | Olympus Corporation of the Americas | 2024-01-10 |