Anti Fog Solution And Accessories, Endoscopy
Gastroenterology, Urology · 21 CFR 876.1500
To prevent, reduce or eliminate condensation (fog) on endoscopic lens.
Recent MDR events
181 adverse event reports on file
- Dr Fog Treated Sponge; SterileJul 28, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00082
- SEE SHARPJul 7, 2026InjuryXodus Medical, Inc.MW5190331
- DR FOG SOLUTION WITH SPONGEJul 7, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00068
- DR FOG TREATED SPONGE, STERILEJul 7, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00070
- DR FOG TREATED SPONGE; STERILEMay 29, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00053
- DR FOG TREATED SPONGE; STERILEMay 7, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00043
- DR FOG TREATED SPONGE, STERILEMar 31, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00029
- DR FOG TREATED SPONGED, STERILEMar 3, 2026MalfunctionAspen Surgical Products, Inc.3002750084-2026-00020
- MEDLINE ANTI-FOG (EU), STERILEDec 23, 2025MalfunctionAspen Surgical Products, Inc.3002750084-2025-00063
- DR FOG TREATED SPONGE; STERILEDec 12, 2025MalfunctionAspen Surgical Products, Inc.3002750084-2025-00067
Event type breakdown
Recalls
2 recall events for this product code
- Medline Industries, Inc.Open, ClassifiedJul 18, 2019
Anti-fog solution packaged in a Tyvek peel pouch and it is placed into various kits. Kit are labeled as follows: ROBOTIC GENERAL, LAP CHOLE, GENERAL LAPAROSCO
The Anti-Fog Solution may not defog properly due to a degradation in the chemical properties.
Z-1984-2019 · View FDA record ↗ - Sunstar Americas, Inc.TerminatedUnknown
BUTLER Clear Dip, 12 bottles/case
Product lacks premarket clearance.
Z-0720-2022 · View FDA record ↗
Registered firms
81 firms currently registered for this product code
Sterigenics Uk Limited
Chesterfield Derbyshire, GB
Covidien
North Haven, CT, US
Sterigenics Us Llc
Gurnee, IL, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Sterigenics Us, Llc
Lewis Center, OH, US
Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urun
ESENYURT Istanbul, TR
Sterilization Services Of Virginia
RICHMOND, VA, US
Maya Medical Top Trade Ltd.
Tsofit Central, IL
Aspen Surgical Products, Inc.
Caledonia, MI, US
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Honduras Kitting, S.a.
Villanueva Cortes, HN
Advanced Medical Design Co., Ltd.
New Taipei City, TW
Conmed Corporation
Utica, NY, US
Isomedix Operations Inc
EL PASO, TX, US
Sterigenics U.s., Llc
Atlanta, GA, US
Xodus Medical, Inc.
New Kensington, PA, US
Consolidated Medical Equipment Company
Chihuahua, MX
Medtronic Distribution Center
Memphis, TN, US
Invotec International, Inc.
Jacksonville, FL, US
Isomedix Operations, Inc.
Libertyville, IL, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Sterigenics Us Llc
Charlotte, NC, US
510(k) clearances
27 clearances for this product code
- Uv One Hygienics, Inc.Aug 27, 2025
K251068 · KnoxFog Anti-fogging Device
- Batrik Medical Manufacturing, Inc.Feb 26, 2024
K231822 · GOLFF Sterile Anti-Fog Solution
- Jdi Surgical, Inc.Jul 7, 2022
K221293 · E-Brik Visualization Assistant
- Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal UrunlerAug 27, 2020
K190864 · Konix Anti-Fog Solution
- Advanced Medical Design Co., Ltd.Jan 22, 2019
K181887 · AMD Anti-Fog Solution
- Sio2 Nanotech, LLCMay 24, 2017
K163257 · VitreOx Anti-fog Solution
- Medline Industries, Inc.Feb 4, 2016
K152948 · Medline Anti-Fog Solution
- Misder, LLCMay 11, 2012
K120821 · LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM