510(k) Report

Devices descending from K161409

6 later devices reach M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc.201753
+2K250032Marquee™ Disposable Core Biopsy Instrument and Instrument KitBard Peripheral Vascular, Inc.20250—
+2K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…Zhejiang Curaway Medical Technology Co., Ltd.20250—
+2K222865M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic…Canyon Medical, Inc.20231—
+2K201166Temno Elite Biopsy SystemMerit Medical Systems, Inc.20200—
+3K233031M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic…Canyon Medical, Inc.20240—