510(k) Report

Devices descending from K964971

394 later devices reach Cryogen Cryosurgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker)20208—
+10K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+10K193162EPi-Sense Guided Coagulation System with VisiTraxAtriCure, Inc.20190—
+10K191851VS3-IRMedtronic20196—
+10K192877Senhance Surgical SystemTransenterix, Inc.20197—
+10K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+10K183107Intuitive Surgical Vessel Sealer ExtendIntuitive Surgical, Inc.20186—
+10K173866Stryker AIM Light Source and SafeLight cableStryker201834—
+10K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+10K162882KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201732—
+10K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+11K254180PerfusiX-ImagingLIMIS Development B.V.20260—
+11K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+11K252632Microwave Ablation DeviceNanjing Dewen Medical Technology Co., Ltd.20260—
+11K253771Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14…Nanjing Devin Medical Technology Co., Ltd.20260—
+11K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+11K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+11K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+11K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+11K250674Vessel Sealer Curved (480522)Intuitive Surgical, Inc.20250—
+11K242983CROMA Electrosurgical Generator (PRD-EMR-050)Creo Medical, Ltd.20250—
+11K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+11K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+11K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+11K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+11K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+11K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+11K231344ActivSight Intraoperative Imaging SystemActiv Surgical, Inc.20230—
+11K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+11K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+11K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+11K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20221—
+11K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+11K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+11K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+11K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+11K200049Senhance Surgical SystemTransenterix, Inc.20206—
+11K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+11K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+11K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+11K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+12K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+12K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+12K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+12K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+12K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+12K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+12K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+12K251324da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+12K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20255—
+12K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+12K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+12K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+12K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+12K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+12K222240Explorer Air® IISurgvision GmbH20231—
+12K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+12K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20220—
+12K221217SPY LaparoscopeStryker20221—
+12K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+12K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+12K202166Senhance Surgical SystemTransenterix, Inc.20215—
+12K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+12K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+12K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+13K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+13K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+13K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+13K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+13K252069da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+13K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+13K251426da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+13K251817da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20251—
+13K252010SPY LaparoscopeStryker Endoscopy20250—
+13K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+13K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+13K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+13K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+13K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+13K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+13K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+13K212054Senhance Surgical SystemAsensus Surgical, Inc.20213—
+13K211325Senhance Surgical SystemAsensus Surgical, Inc.20210—
+13K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+14K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+14K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+14K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+14K230754L12 LED Light Source with AIMStryker20236—
+14K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+14K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+14K221611780 nm L11 LED Light Source with AIMStryker202210—
+14K220889Senhance Surgical SystemAsensus Surgical, Inc.20222—
+14K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—
+15K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—