510(k) K193036 ยท OCX Endoscopic Irrigation/Suction System
C2 CryoBalloon EndoGrip
| Applicant | Pentax Medical, A Division of Pentax of America, Inc., Redwood, Ca CA, US |
| Decision | Substantially Equivalent, Nov 22, 2019 |
| Received | Oct 31, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193036
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.