510(k) Report

Devices descending from K953484

21 later devices reach Pollux OA/Pollux 30A/Pollux 70A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082841Spinal ForaminoscopeBlazejewski Medi-Tech GmbH200920—
+2K141326Needle View CH Scope KitsBiovision Technologies, LLC20143—
+2K130778Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH201414—
+2K123330Iogyn EndoscopeIogyn, Inc.20130—
+3K243602Arthrex Spine EndoscopeArthrex, Inc.20250—
+3K181982MIDAScope and Introducer Kit, and MIDASystemIntravu, Inc.20182—
+3K180766Endiscope, Endiscope CervicalElliquence, LLC201812—
+4K243020MIDASVuIntravu, Inc.20241—
+4K201134Arthrex NanoScope SystemArthrex, Inc.202011—
+5K260414“Tech-Image” Video Endoscope SystemTech-Image CO., LTD.20260—
+5K252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.20260—
+5K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…Medimaging Integrated Solution, Inc (Miis)20250—
+5K241990SpineSite Endoscope SystemHydrocision, Inc.20250—
+5K243008Arthrex NanoScope SystemArthrex, Inc.20254—
+5K223759Arthrex SynergyID Endoscopic Imaging SystemArthex, Inc.20234—
+6K252640VereSee Optical Veres Needle and Endoscopic CameraFreyja Healthcare, LLC20251—
+6K250728Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20251—
+6K233451Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20243—
+7K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC20260—
+7K251994Arthrex Synergy Vision Imaging SystemArthrex, Inc.20250—
+7K241361Arthrex Synergy Vision Endoscopic Imaging SystemArthrex, Inc.20242—