510(k) Report

Devices descending from K103389

25 later devices reach Truclear Incisor Plus Blade 2.9 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132015Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc.2013241
+2K223520UNIDRIVE SIII SystemKarl Storz-Endoscopy-America, Inc.20232—
+2K190372Aveta SystemMeditrina, Inc.20194—
+2K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc.20160—
+2K142029Myosure Hysteroscopic Tissue Removal SystemHologic, Inc.201414—
+3K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD)…Karl Storz SE & CO. KG20260—
+3K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG20260—
+3K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+3K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+3K191958Aveta SystemMeditrina, Inc.20190—
+3K173901MyoSure MANUAL Tissue Removal DeviceHologic, Inc.20184—
+3K170120EndoRotorInterscope, Inc.20171—
+3K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.20156—
+4K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.20260—
+4K223813Aveta System 2.0Meditrina, Inc.20230—
+4K201756Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal…Stryker Sustainability Solutions20200—
+4K191538Resectr Tissue Resection DeviceBoston Scientific Corporation20201—
+4K182675Polygon Resection DevicePolygon Medical, Inc.20190—
+4K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set…Interscope, Inc.20190—
+4K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.20175—
+5K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.20260—
+5K181974MyoSure XL Tissue Removal Device for FluentHologic, Inc.20181—
+5K180825Fluent Fluid Management SystemHologic, Inc.20182—
+6K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…Hologic, Inc.20240—
+6K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.20240—