ENDOEYE HD II
FDA 510(k) clearance K111788 · decided 2012-01-13
Clearance details
- K-number
- K111788
- Device name
- ENDOEYE HD II
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-06-24
- Decision date
- 2012-01-13
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- HET
- Device class
- 2
- Regulation number
- 884.1720
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus ENDOEYE HD II Video Telescopes Models: WA50040A Endoeye HD II, 10 mm, 0 deg., auto recall (Z-1929-2017) | Olympus Corporation of the Americas | 2017-02-21 |
| Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0 degree, WA recall (Z-0403-2016) | Olympus Corporation of the Americas | 2015-12-10 |