510(k) Report

Devices descending from K160316

4 later devices reach SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212820Disposable Semi Automatic Biopsy InstrumentSuzhou Leapmed Healthcare Corporation20220—
+1K212822Disposable Coaxial Biopsy NeedleSuzhou Leapmed Healthcare Corporation20220—
+1K212819Disposable Biopsy Refill NeedleSuzhou Leapmed Healthcare Corporation20220—
+1K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131…Guangzhou Shengwei Medical Devices Co., Ltd.20220—