510(k) Report

Devices descending from K925699

468 later devices reach Harmonic Scalpel Laparosonic Clamp Coagulator Acc. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K203504Cios FlowSiemens Medical Solutions USA, Inc.202091
+10K193326ARTIS IconoSiemens Medical Solutions USA, Inc.2020013
+10K200049Senhance Surgical SystemTransenterix, Inc.20206—
+10K192293uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd.20191—
+10K191418Multix Fusion MaxSiemens Medical Solutions USA, Inc.20190—
+10K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc.20198—
+10K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+10K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+10K163715Allura Xper R9Philips Medical Systems Nederland B.V.20177Class I
+10K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V.20161Class I
+10K161756SyncVision SystemVolcano Corporation201611
+11K253296Digital C-ARM with 3DAllengers Medical Systems Limited20260—
+11K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+11K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+11K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+11K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+11K251199Allia MoveoGE Medical Systems SCS202501
+11K252069da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+11K252000uDR Arria & uDR ArisShanghai United Imaging Healthcare Co., Ltd.20250—
+11K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+11K251426da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+11K251817da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20251—
+11K250738YSIO X.preeSiemens Medical Solutions20250—
+11K251523Cios SpinSiemens Medical Solutions USA, Inc.20250—
+11K252010SPY LaparoscopeStryker Endoscopy20250—
+11K251520Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc.20250—
+11K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+11K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+11K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+11K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+11K233748CIARTIC Move (VB10)Siemens Medical Solutions USA, Inc.20240—
+11K230949ARTIS pheno (VE30A)Siemens Medical Solutions USA, Inc.202332
+11K230950ARTIS icono (VE30A)Siemens Medical Solutions USA, Inc.202331
+11K223410Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc.20221—
+11K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+11K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+11K220311Cardiovascular Angiography SystemAllengers Medical Systems Limited20220—
+11K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+11K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+11K202166Senhance Surgical SystemTransenterix, Inc.20215—
+11K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+11K193089MULTIX ImpactSiemens Medical Solutions USA, Inc.20207—
+11K172822Azurion series R1.2Philips Medical Systems Nederland B.V.20176Class I
+11K172574SyncVision SystemVolcano Corporation201701
+12K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+12K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+12K250241Cios SelectSiemens Medical Solutions USA, Inc.20250—
+12K230754L12 LED Light Source with AIMStryker20236—
+12K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+12K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+12K221611780 nm L11 LED Light Source with AIMStryker202210—
+12K212054Senhance Surgical SystemAsensus Surgical, Inc.20213—
+12K211325Senhance Surgical SystemAsensus Surgical, Inc.20210—
+12K203345MULTIX ImpactSiemens Medical Solutions USA, Inc.20215—
+12K203340MULTIX Impact CSiemens Medical Solutions USA, Inc.20213—
+12K200917Azurion R2.1Philips Medical Systems Nederland B.V.20204Class I
+12K181830Azurion R2.0Philips Medical Systems Nederland B.V.2018542
+13K251827Azurion R3.1Philips Medical Systems B.V.20251—
+13K243376uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20251—
+13K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+13K220889Senhance Surgical SystemAsensus Surgical, Inc.20222—
+13K220919MULTIX Impact ESiemens Medical Solutions USA, Inc.20222—
+13K213700MULTIX Impact, MULTIX Impact CSiemens Medical Solutions USA, Inc.20212—
+14K260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.20260—
+14K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.20260—
+14K254186Azurion R3.1Philips Medical Systems B.V.20260—
+14K242499Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))Shenzhen Sontu Medical Imaging Equipment Co., Ltd.20250—
+14K233532MULTIX Impact ESiemens Medical Solutions20230—