510(k) K242699 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12)
| Applicant | Opcom Medical, Inc., New Taipei City, TW |
| Decision | Substantially Equivalent, May 28, 2025 |
| Received | Sep 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242699
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.