510(k) Report

Devices descending from K141552

11 later devices reach Achieve Programmable Auomated Biopsy Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…Zhejiang Curaway Medical Technology Co., Ltd.20250—
+1K243095Mammotome AutoCore™ Single Insertion Core Biopsy SystemDevicor Medical Products, Inc.20240—
+1K192101Medone Ultra, MedextraMedax Srl Unipersonale20202—
+1K191472Biopsy NeedleUshare Medical, Inc.20200—
+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—
+2K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd.20211—
+3K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.20260—