510(k) Report

Devices descending from K960064

22 later devices reach Temno Achieve Biopsy Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…M.D.L. S.R.L.201641
+1K150169Sertera Biopsy DeviceHologic, Inc.201503
+1K141552Achieve Programmable Auomated Biopsy SystemsCare Fusion201411—
+1K130616Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-NeedlesBiopsybell S.R.L.201472
+1K093256Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018Inrad20090—
+2K241793Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…Zhejiang Curaway Medical Technology Co., Ltd.20250—
+2K243095Mammotome AutoCore™ Single Insertion Core Biopsy SystemDevicor Medical Products, Inc.20240—
+2K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15)…Itp Innovative Tomography Products GmbH20231—
+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—
+2K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L.20210—
+2K192101Medone Ultra, MedextraMedax Srl Unipersonale20202—
+2K191472Biopsy NeedleUshare Medical, Inc.20200—
+2K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)Medax Srl Unipersonale20171—
+2K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171—
+3K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical20250—
+3K233294Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMItp Innovative Tomography Products GmbH20240—
+3K210946Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…Promisemed Hangzhou Meditech Co., Ltd.20211—
+3K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale20200—
+4K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.20260—