510(k) K203526 ยท HRX Arthroscope
C Scope Visualization System
| Applicant | Cit Ortho, Westlake OH, US |
| Decision | Substantially Equivalent, Jan 12, 2021 |
| Received | Dec 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203526
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2025 | MEDLINE INDUSTRIES, LP - Northfield Medline procedure kits labeled as:
1) C SCOPE DISPOSABLE KIT, Pack Number 613034700,
2) C SCOPE DISPOSABLE KIT, Pack Number 613034702 Open, Classified |
HRX | None listed |
| Sep 6, 2024 | MEDLINE INDUSTRIES, LP - Northfield Medline Convenience kits labeled as:
1) C SCOPE DISPOSABLE KIT, Pack Code 613034700;
2) C SCOPE DISPOSABLE KIT, Pack Code 613034701;
3) C SCOPE DISPOSABLE KIT, Pack Code 613034702 Open, Classified |
HRX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.