ClearanceBrief
510(k) K250708 ยท OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus

NPseal

ApplicantGuard Medical, Inc., Miami FL, US
DecisionSubstantially Equivalent, Apr 8, 2025
ReceivedMar 10, 2025
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K250708

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.