510(k) Report

Devices descending from K031080

155 later devices reach Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+8K251336VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light…Olympus Medical Systems Corp.20250—
+8K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+8K252350da Vinci SP Firefly Imaging SystemIntuitive Surgical, Inc.20250—
+8K242318da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20247—
+8K241814da Vinci SP Instruments (SP1098)Intuitive Surgical, Inc.20240—
+8K241530Stellar Imaging SystemGuangdong Optomedic Technologies, Inc.20241—
+8K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+8K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+8K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+8K230407FloNavi Open Field Fluorescence Imaging SystemGuangdong Optomedic Technologies, Inc.20230—
+8K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker)20234—
+8K223020VS3-Iridium System (VS3-IR)Visionsense, Ltd.20220—
+8K210265VS3 Iridium SytemVisionsense, Ltd.20215—
+8K212695KARL STORZ ICG Imaging SystemKarl Storz Endoscopy America20215—
+8K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+8K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker)20205—
+9K262547KARL STORZ TIPCAM1 RubinaKALR STORZ SE & Co. KG20260—
+9K253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage Corporation20260—
+9K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KG20260—
+9K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+9K2526973D LaparoscopeGuangdong Optomedic Technologies, Inc.20250—
+9K243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbH20250—
+9K251324da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+9K243714da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20255—
+9K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+9K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+9K233333KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control UnitKarl Storz SE & CO. KG20232—
+9K232857KARL STORZ ICG Imaging SystemKarl Storz SE & CO. KG20230—
+9K222240Explorer Air® IISurgvision GmbH20231—
+9K221217SPY LaparoscopeStryker20221—
+9K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies20221—
+9K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+10K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+10K251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.20260—
+10K253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG20260—
+10K252675da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+10K252069da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+10K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+10K251426da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20250—
+10K251817da Vinci SP Surgical System (SP1098)Intuitive Surgical, Inc.20251—
+10K252010SPY LaparoscopeStryker Endoscopy20250—
+10K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+10K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH20240—
+10K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+10K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+10K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+10K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+11K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+11K253556da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorIntuitive Surgical, Inc.20260—
+11K230754L12 LED Light Source with AIMStryker20236—
+11K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+11K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+11K221611780 nm L11 LED Light Source with AIMStryker202210—
+12K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—