510(k) Report

Devices descending from K790187

66 later devices reach Bovie Hand Control through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023311Loop Microwave Ablation ProbeVivant Medical, Inc.200328—
+1K022286Encircle Localization DeviceVivant Medical, Inc.20020—
+1K012004Easy Guide Electrosurgical Access DeviceSenorx, Inc.20012—
+1K012023Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableSenorx, Inc.200131—
+1K012799ES-2000 Shape Select Electrosurgical ScalpelSenorx, Inc.20012—
+2K070275Flexible Loop Electrosurgical ElectrodeRubicor Medical, Inc.20070—
+2K040279Vivaring Microwave Ablation ProbeVivant Medical, Inc.20043—
+2K032047Tri-Loop Microwave Ablation ProbeVivant Medical, Inc.200327—
+2K022314Sanarus Visica Treatment SystemSanarus Medical, Inc.2002291
+2K021707Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step…Senorx, Inc.20020—
+2K013641Senorx Biopsy Device, Driver, Control Module, Including Accessories (Power…Senorx, Inc.20021—
+3K141785Micro Thermx Microwave Ablation System and AccessoriesBsd Medical Corp.20150—
+3K081042Microthermx-100 Microwave Ablation System and AccessoriesBsd Medical Systems Corp.20082—
+3K061510Sanarus Visica Treatment SystemSanarus Medical, Inc.200627—
+3K052861Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc.200528—
+3K032702Vivatip Microwave Ablation ProbeVivant Medical, Inc.200326—
+4K150019TheraVision Ultrasound Ablation System and ACOUSTx ApplicatorsAcoustic Medsystems, Inc.20160—
+4K100786Microthermx Microwave Ablation System, Models MTX-180 or MTXBsd Medical Corp.20101—
+4K083157HS AmicaH.S Hospital Service S.P.A20094—
+4K062896V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Sanarus Medical, Inc.200726—
+4K052919Microsulis Tissue Ablation SystemMicrosulis Americas, Inc.200615—
+5K223272SurBlate Ablation SystemMima-Pro Scientific, Inc.20230—
+5K150112HS Amica Devices FamilyH.S Hospital Service S.P.A20152—
+5K102360Icesence 3IceCure Medical, Ltd.2010251
+5K072870Microwave Tissue Coagulation System (MTCS)Foundry Newco X, Inc.200811—
+5K070356Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated20072—
+6K183213IceSense 3, ProSense, MultiSenseIceCure Medical, Ltd.20193—
+6K182605HS AMICA devices familyH.S Hospital Service S.P.A20191—
+6K181941Swift SystemEmblation, Ltd.20183—
+6K143203AveCure Microwave Coagulation-Ablation Generator, AveCure Microwave Large Antenna-Probe…Medwaves Incorporated20150—
+6K133258Trufreeze SystemCSA Medical, Inc.2014201
+6K082819Dermatologic Treatment System (DTS) G2Miramar Labs, Inc.200910—
+6K083537Modification to Medwaves Microwave Coagulation/Ablation SystemMedwaves Incorporated20091—
+7K250718swiftPro System (SWF-SPS); Swift System (SWF-SYS)Emblation Limited20250—
+7K240892XSense Cryoablation System with CryoprobesIceCure Medical, Ltd.20242—
+7K232072Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GH.S Hospital Service S.P.A20240—
+7K222388swiftPro SystemEmblation, Ltd.20232—
+7K143625truFreeze SystemCSA Medical, Inc.2015191
+7K103014Miradry SystemMiramar Labs, Inc.201152
+8K260377XSense Cryoablation System with CryoProbesIceCure Medical, Ltd.20260—
+8K243042Co-Ablation System with Sterile Co-Ablation ProbeHygea Medical Technology Co., Ltd.20250—
+8K240518swiftPro™ SystemEmblation Limited20241—
+8K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+8K152668truFreeze SystemCSA Medical, Inc.201510—
+8K150920truFreeze SystemCSA Medical, Inc.201511—
+8K141511SIDELAZE800 Laser Beam Delivery Accessory for Cynosure 1440MM Wavelength LasersCynosure, Inc.20150—
+8K131162Miradry SystemMiramar Labs, Inc.201331
+9K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+9K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+9K160273truFreeze SystemCsa Medial, Inc.20169—
+9K150419miraDry System MD4000Miramar Labs, Inc.201521
+10K190194C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2…Pentax Medical, A Division of Pentax of America, Inc.20193—
+10K160141miraDry SystemMiramar Labs, Inc.20161—
+10K161557truFreeze SystemCSA Medical, Inc.20168—
+11K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…Pentax of America, Inc.20202—
+11K180396miraDry SystemMiramar Labs, Inc.20180—
+11K162695truFreeze SystemCSA Medical, Inc.20167—
+12K212814C2 CryoBalloon Ablation SystemPentax of America, Inc.20211—
+12K171522truFreeze Rapid AV Spray KitCSA Medical, Inc.20170—
+12K163244truFreeze SystemCSA Medical, Inc.20175—
+13K240457C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)Pentax of America, Inc.20240—
+13K171626truFreeze SystemCSA Medical, Inc.20173—
+13K172041truFreeze SystemCSA Medical, Inc.20170—
+14K222272truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20221—
+14K201183Vortex Radial Spray CatheterCSA Medical, Inc.20200—
+15K223369truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5…STERIS Corporation20220—