510(k) Report

Devices descending from K934371

6 later devices reach Bip Multi Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242228Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle…Triopsy Medical, Inc.20250—
+1K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L.201641
+2K212820Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation20220—
+2K212822Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation20220—
+2K212819Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation20220—
+2K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131…Guangzhou Shengwei Medical Devices Co., Ltd.20220—