510(k) Report

Devices descending from K080613

16 later devices reach Clear-VU System, Models: CVL-01-1000, CVL-01-1030, CVL-01-1045 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260710FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm…FloShield, Inc.20260—
+1K171637OpClear SystemCipher Surgical, Ltd.20183—
+1K153773Disposal Lens Cleaning SheathOlympus Medical Systems Corp.20160—
+1K151117Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.20158—
+1K102452Defogging and Cleaning Solution- Flo-XMinimally Invasive Devices, LLC20100—
+2K222695troCarWash™ SystemBiotex, Inc.20231—
+2K221824OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear…Cipher Surgical Limited20220—
+2K160172Laparoscope Lens Shield DeviceMedeon Biodesign, Inc.20167—
+3K233442troCarWash™ SystemBiotex, Inc.20240—
+3K170103Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc.20176—
+4K200228ClearCam SystemClearcam, LLC20203—
+4K192891Laparoscope Lens Shield Device (LENS)Medeon Biodesign, Inc.20194—
+5K241796TroCare TroKit Laparoscope Lens Wiper (CP000626)TroCare, LLC20242—
+5K200902ClickCleanMedeon Biodesign, Inc.20200—
+6K253994TroKit Laparoscope Lens WiperTroCare, LLC20260—
+6K260089TL-10 Laparoscopic Scope CleanerScopix, Ltd.20260—