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OCT — Anti Fog Solution And Accessories, Endoscopy Class II

FDA Device Classification

Classification Details

Product Code
OCT
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To prevent, reduce or eliminate condensation (fog) on endoscopic lens.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251068uv one hygienicsKnoxFog Anti-fogging DeviceAugust 27, 2025
K231822batrik medical manufacturingGOLFF Sterile Anti-Fog SolutionFebruary 26, 2024
K221293jdi surgicalE-Brik Visualization AssistantJuly 7, 2022
K190864turkuaz saglik hizmetleri medikal temizlik kimyasal urunlerKonix Anti-Fog SolutionAugust 27, 2020
K181887advanced medical design coAMD Anti-Fog SolutionJanuary 22, 2019
K163257sio2 nanotechVitreOx Anti-fog SolutionMay 24, 2017
K152948medline industriesMedline Anti-Fog SolutionFebruary 4, 2016
K120821misderLLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEMMay 11, 2012
K111622unimax medical systemsUNIMAX ANTI-FOG SOLUTIONSeptember 9, 2011
K102452minimally invasive devicesDEFOGGING AND CLEANING SOLUTION- FLO-XDecember 23, 2010
K080613minimally invasive devicesCLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045November 6, 2008
K063587xodus medicalXODUS MEDICAL ANTI-FOG SOLUTIONJanuary 9, 2007
K051979o.r. solutionsORS MODEL 6000 ENDOSCOPE HOLDERAugust 30, 2005
K022826preservation solutionsCLEAR-IT ANTI-FOG, MODEL PS003October 9, 2002
K993604mectra labsENDOSCOPIC ANTI FOG DEVICEMarch 3, 2000
K982465deroyal industriesDEROYAL INDUSTRIES, INC. DEFOGGERAugust 11, 1998
K974454tucson medicalCLEARFIELD ANTI-FOG STERILE WIPE, PRODUCT NUMBER 300-004December 18, 1997
K945732tonn chemical coFOG FREEJanuary 4, 1995
K942576white knight healthcareCLEAR LENS ENDOSCOPIC FOG REDUCTION DEVICEJuly 5, 1994
K923843sorex medicalFOGLESSMarch 25, 1994