VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
FDA 510(k) clearance K022445 · decided 2003-01-24
Clearance details
- K-number
- K022445
- Device name
- VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V
- Applicant
- Olympus Optical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-07-25
- Decision date
- 2003-01-24
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Visera Hysterovideoscope Olympus HYF Type V recall (Z-2480-2023) | Olympus Corporation of the Americas | 2023-08-29 |