ClearanceBrief
510(k) K252021 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology

Disposable Endoscopic Injection Needles

ApplicantChangzhou New Med Micro-Medtech Co., Ltd., Changzhou, CN
DecisionSubstantially Equivalent, Dec 2, 2025
ReceivedJun 30, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252021

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.