510(k) Report

Devices descending from K936194

6 later devices reach Coaxial Biopsy Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181756Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial NeedleApriomed AB20180—
+1K160423Perineologic Access NeedleCorbin Clinical Resources, LLC20162—
+1K151373Corvocet Coaxial IntroducerMerit Medical Systems, Inc.201501
+1K133148Biomarc Coaxial NeedleCarbon Medical Technologies, Inc.20140—
+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—