ClearanceBrief
510(k) K223249 ยท PCT Prostate Immobilizer Rectal Balloon

Pro-Tx Endorectal Balloon (PROT-25)

ApplicantDxtx Medical, Inc., Pittsburgh PA, US
DecisionSubstantially Equivalent, Feb 10, 2023
ReceivedSep 12, 2022
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K223249

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.