ADULT RESECTOSCOPE
FDA 510(k) clearance K890328 · decided 1990-02-06
Clearance details
- K-number
- K890328
- Device name
- ADULT RESECTOSCOPE
- Applicant
- Circon Video
- Decision
- Substantially Equivalent
- Date received
- 1989-01-23
- Decision date
- 1990-02-06
- Days to decision
- 379 days
- Clearance type
- Traditional
- Product code
- HIH
- Device class
- 2
- Regulation number
- 884.1690
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Stanford, CT, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. recall (Z-2140-2025) | Olympus Corporation of the Americas | 2025-07-21 |
| ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA recall (Z-0568-2024) | Olympus Corporation of the Americas | 2023-12-15 |