OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
FDA 510(k) clearance K111425 · decided 2012-04-20
Clearance details
- K-number
- K111425
- Device name
- OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-23
- Decision date
- 2012-04-20
- Days to decision
- 333 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 FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used with recall (Z-0645-2024) | Olympus Corporation of the Americas | 2024-01-05 |