510(k) Report

Devices descending from K970514

15 later devices reach Disposable Transrectal/Transvaginal/Endocavity Ultrasound Needle Instrument… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223689Disposable Needle Guides and GridsAdvance Medical Designs, Inc.20231—
+1K222052VitroPROCIVCO Medical Instruments Co., Inc.20222—
+1K082919UC-Care Positioning SystemUc-Care Medical Systems, Ltd.20080—
+1K041637Targetscan Transrectal Ultrasound SystemEnvisioneering, LLC20048—
+2K261170BA-004CCFujifilm Corporation20260—
+2K260161SmartGuide Disposable Guides and GridsUC-CARE, Ltd.20260—
+2K231783VitroPROCIVCO Medical Instruments Co., Inc.20230—
+2K163502iSR'obot Biopsy KitBiobot Surgical Pte., Ltd.20172—
+2K111347Isrobot Mona LisaBiobot Surgical Pte., Ltd.20114—
+2K073399Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC20071—
+3K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+3K130944Isr'obot Mona LisaBiobot Surgical Pte., Ltd.20133—
+3K081323Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818B-K Medical Aps20080—
+4K232320iSR`obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20230—
+4K203659iSR'obot Mona Lisa 1.0Biobot Surgical Pte., Ltd.20212—