510(k) K241213 ยท FDS Gastroscope And Accessories, Flexible/Rigid
PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Dec 6, 2024 |
| Received | Apr 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241213
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.