510(k) K251256 ยท FDS Gastroscope And Accessories, Flexible/Rigid
PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Dec 16, 2025 |
| Received | Apr 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251256
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.