510(k) Report

Devices descending from K945088

40 later devices reach Gabriel Ureteral Illuminator System II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K982542Stryker Ureteral Illuminator System IiiStryker Endoscopy1998361
+1K960173Infra Vision Bougie Kit, Infra Vision Esophageal KitGabriel Medical, Inc.19962—
+2K061548Stryker Ureteral Illumination System IVStryker Corp.200635—
+2K983220Stryker Infravision Esophageal KitStryker Endoscopy199912
+3K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]Stryker Endoscopy201534—
+3K130906Endoflip CatheterCrospon, Ltd.20130—
+4K192292L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight CableStryker20191—
+4K1821601688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head…Stryker2018331
+5K243591OPTOVISION Endoscopic Light Source UnitOptosurgical, LLC20250—
+5K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Schoelly Fiberoptic GmbH20231—
+5K202592Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality…Stryker202026—
+5K2003101688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with…Stryker20200—
+5K191046L10 LED Light Source with AIM, L11 LED Light Source with AIMStryker20192—
+6K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head…Schoelly Fiberoptic GmbH20240—
+6K2100881688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM…Stryker202125—
+7K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+7K221217SPY LaparoscopeStryker20221—
+7K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S…Stryker202119—
+8K253602Precision S 4K SinuscopeStryker Endoscopy20260—
+8K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+8K252010SPY LaparoscopeStryker Endoscopy20250—
+8K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+8K2221301688 4K Camera System with Advanced Imaging ModalityStryker20220—
+8K214046780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight CableStryker202214—
+8K2208951688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K…Stryker20220—
+8K2125111688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K…Stryker20210—
+9K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+9K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+9K230754L12 LED Light Source with AIMStryker20236—
+9K2306051788 4K Camera System with Advanced Imaging ModalityStryker20236—
+9K2302161688 4K Camera Control Unit with Advanced Imaging Modality (1688010000)Stryker20238—
+9K221611780 nm L11 LED Light Source with AIMStryker202210—
+10K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—
+10K2401741688 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+10K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+11K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+11K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+11K2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…Stryker Endoscopy20260—
+11K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+11K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—