510(k) Report

Devices descending from K964441

39 later devices reach Femrx Focused Monopolar (Fap) Operastar System [Outpatient Endoscopic… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031787Smith & Nephew Iur Morcellation SystemSmith & Nephew, Inc.2003371
+1K971305Femrx Focused Monopolar (FMP) Opera Star SystemGynecare Innovation Center19970—
+2K132015Truclear Morcellation System and Truclear MorcellatorsSmith & Nephew, Inc.2013241
+2K110038Truclear Morcellator SystemSmith & Nephew, Inc.201125—
+2K103389Truclear Incisor Plus Blade 2.9Smith & Nephew, Inc.201125—
+2K041774Iur Reciprocating Morcellator Model # 7210517Smith & Nephew, Inc.200434—
+3K223520UNIDRIVE SIII SystemKarl Storz-Endoscopy-America, Inc.20232—
+3K190372Aveta SystemMeditrina, Inc.20194—
+3K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal DeviceSmith & Nephew, Inc.20160—
+3K142029Myosure Hysteroscopic Tissue Removal SystemHologic, Inc.201414—
+3K073690Interlace Medical Hysteroscopic Morcellation SystemInterlace Medical, Inc.20088—
+4K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD)…Karl Storz SE & CO. KG20260—
+4K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG20260—
+4K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc.20221—
+4K192100Aveta Disposable HysteroscopeMeditrina, Inc.20190—
+4K191958Aveta SystemMeditrina, Inc.20190—
+4K173901MyoSure MANUAL Tissue Removal DeviceHologic, Inc.20184—
+4K170120EndoRotorInterscope, Inc.20171—
+4K152723Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.20156—
+4K091100Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc.20097—
+5K254050Manual Tissue Removal DeviceSuzhou AcuVu Medical Technology Co., Ltd.20260—
+5K223813Aveta System 2.0Meditrina, Inc.20230—
+5K201756Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal…Stryker Sustainability Solutions20200—
+5K191538Resectr Tissue Resection DeviceBoston Scientific Corporation20201—
+5K182675Polygon Resection DevicePolygon Medical, Inc.20190—
+5K181127EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set…Interscope, Inc.20190—
+5K172566Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal DevicesHologic, Inc.20175—
+5K103741Surgisure Tissue Removal SystemInterlace Medical, Inc.20110—
+5K100559Myosure Hysteroscopic Tissue Removal SystemInterlace Medical, Inc.20106—
+6K260984HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)Axora Medical, Inc.20260—
+6K181974MyoSure XL Tissue Removal Device for FluentHologic, Inc.20181—
+6K180825Fluent Fluid Management SystemHologic, Inc.20182—
+6K131581Myosure Tissue Removal Device (1 Pack and 3 Pack)Hologic, Inc.20130—
+6K122498Myosure XL Tissue Removal Device (1 Pack) Myosure XL Tissue Removal Device (3 Pack)Hologic, Inc.20121—
+6K121868Myosure Lite Tissue Removal Device (1 Pack), Myosure Lite Tissue Removal Device (3 Pack)Hologic, Inc.20120—
+6K120593Myosure Control UnitHologic, Inc.20120—
+7K240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System…Hologic, Inc.20240—
+7K233710Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc.20240—
+7K131736Myosure Tissue Removal Device (1 Pack), Myosure Tissue Removal Device (3 Pack)Hologic, Inc.20130—