510(k) Report

Devices descending from K002489

263 later devices reach Intuitive Surgical DA Vinci Endoscopic Control System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20220—
+7K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+7K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+7K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+7K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+7K200049Senhance Surgical SystemTransenterix, Inc.20206—
+7K191280E-100 Electrosurgical Generator, SynchroSealIntuitive Surgical, Inc.201942
+7K180146KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America, Inc.201830—
+7K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc.201731—
+7K170430TSolution One Surgical System Model 210THINK Surgical, Inc.20176—
+8K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+8K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+8K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+8K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+8K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+8K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+8K251324da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+8K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20255—
+8K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+8K233391cCeLL - In vivoVPIX Medical, Inc.20240—
+8K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+8K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+8K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+8K222240Explorer Air® IISurgvision GmbH20231—
+8K223039da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20223—
+8K221217SPY LaparoscopeStryker20221—
+8K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+8K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+8K202166Senhance Surgical SystemTransenterix, Inc.20215—
+8K201399HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid…Karl Storz-Endoscopy-America, Inc.20208—
+8K191369TSolution One Total Knee ApplicationTHINK Surgical, Inc.20195—
+9K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+9K252037CUVIS-joint (CJ150)Curexo, Inc.20260—
+9K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+9K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+9K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K252069da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+9K251426da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K251817da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20251—
+9K252010SPY LaparoscopeStryker Endoscopy20250—
+9K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+9K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+9K231212da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20232—
+9K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+9K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+9K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+9K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+9K212054Senhance Surgical SystemAsensus Surgical, Inc.20213—
+9K211325Senhance Surgical SystemAsensus Surgical, Inc.20210—
+9K201255TSolution® One Total Knee ApplicationTHINK Surgical, Inc.20203—
+9K193135TSolution One Total Knee ApplicationTHINK Surgical, Inc.20194—
+10K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+10K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+10K241635da Vinci E-200 Electrosurgical GeneratorIntuitive Surgical20241—
+10K230754L12 LED Light Source with AIMStryker20236—
+10K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+10K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+10K221611780 nm L11 LED Light Source with AIMStryker202210—
+10K220889Senhance Surgical SystemAsensus Surgical, Inc.20222—
+10K203040TSolution One Total Knee ApplicationTHINK Surgical, Inc.20202—
+11K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+11K210668TSolution One Total Knee ApplicationTHINK Surgical, Inc.20210—