OLYMPUS HYSTERORESECTOSCOPE
FDA 510(k) clearance K897003 · decided 1990-03-16
Clearance details
- K-number
- K897003
- Device name
- OLYMPUS HYSTERORESECTOSCOPE
- Applicant
- Olympus Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-18
- Decision date
- 1990-03-16
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Lake Success, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OES 4000 Hysteroscope, Model/Catalog Number: A4674A recall (Z-2029-2024) | Olympus Corporation of the Americas | 2024-06-06 |