OCT
- 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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251068 | 2025-08-27 | Uv One Hygienics, Inc. | KnoxFog Anti-fogging Device | |
| K231822 | 2024-02-26 | Batrik Medical Manufacturing, Inc. | GOLFF Sterile Anti-Fog Solution |
Official FDA classification page: OCT
Classification and pathway per current FDA publications. Data from openFDA (CC0).