OCT

Anti Fog Solution And Accessories, Endoscopy

Product code
OCT
Device name
Anti Fog Solution And Accessories, Endoscopy
Device class
Class 2
21 CFR
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
27 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-08-27.

NumberDecision dateApplicantDevice nameSummary
K2510682025-08-27Uv One Hygienics, Inc.KnoxFog Anti-fogging DevicePDF
K2318222024-02-26Batrik Medical Manufacturing, Inc.GOLFF Sterile Anti-Fog SolutionPDF

2 summaries are archived here for direct download.

Official FDA classification page: OCT
Classification and pathway per current FDA publications. Data from openFDA (CC0).