FDA.reportPublic FDA data

510(k) K231822

Device
GOLFF Sterile Anti-Fog Solution
Applicant
Batrik Medical Manufacturing, Inc.
510(k) number
K231822
Product code
OCT
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-26
Date received
2023-06-21
Regulation
876.1500
Classification name
Anti Fog Solution And Accessories, Endoscopy
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Suzy Bairos
Address
2165 46th Ave. Lachine CA H8T 2P1 H8T 2P1

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OCT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.2025-08-27
K221293E-Brik Visualization AssistantJdi Surgical, Inc.2022-07-07
K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler2020-08-27
K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd.2019-01-22
K163257VitreOx Anti-fog SolutionSio2 Nanotech, LLC2017-05-24
K152948Medline Anti-Fog SolutionMedline Industries, Inc.2016-02-04
K120821LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEMMisder, LLC2012-05-11
K111622UNIMAX ANTI-FOG SOLUTIONUnimax Medical Systems, Inc.2011-09-09
K102452DEFOGGING AND CLEANING SOLUTION- FLO-XMinimally Invasive Devices, LLC2010-12-23
K080613CLEAR-VU SYSTEM, MODELS: CVL-01-1000, CVL-01-1030, CVL-01-1045Minimally Invasive Devices, LLC2008-11-06
K063587XODUS MEDICAL ANTI-FOG SOLUTIONXodus Medical, Inc.2007-01-09
K051979ORS MODEL 6000 ENDOSCOPE HOLDERO.R. Solutions, Inc.2005-08-30
K022826CLEAR-IT ANTI-FOG, MODEL PS003Preservation Solutions, Inc.2002-10-09
K993604ENDOSCOPIC ANTI FOG DEVICEMectra Labs, Inc.2000-03-03
K982465DEROYAL INDUSTRIES, INC. DEFOGGERDeroyal Industries, Inc.1998-08-11