K231822 is an FDA 510(k) clearance for the GOLFF Sterile Anti-Fog Solution. This device is classified as a Anti Fog Solution And Accessories, Endoscopy (Class II - Special Controls, product code OCT).
Submitted by Batrik Medical Manufacturing, Inc. (Lachine, CA). The FDA issued a Cleared decision on February 26, 2024, 250 days after receiving the submission on June 21, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens..
| 510(k) Number | K231822 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2023 |
| Decision Date | February 26, 2024 |
| Days to Decision | 250 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | OCT - Anti Fog Solution And Accessories, Endoscopy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens. |