C Scope Visualization System
FDA 510(k) clearance K203526 · decided 2021-01-12
Clearance details
- K-number
- K203526
- Device name
- C Scope Visualization System
- Applicant
- Cit Ortho
- Decision
- Substantially Equivalent
- Date received
- 2020-12-02
- Decision date
- 2021-01-12
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Westlake, OH, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C recall (Z-1453-2025) | MEDLINE INDUSTRIES, LP - Northfield | 2025-03-25 |
| Medline Convenience kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Code 613034700; 2) C recall (Z-3053-2024) | MEDLINE INDUSTRIES, LP - Northfield | 2024-09-06 |