K152948 is an FDA 510(k) clearance for the Medline Anti-Fog Solution. This device is classified as a Anti Fog Solution And Accessories, Endoscopy (Class II - Special Controls, product code OCT).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on February 4, 2016, 121 days after receiving the submission on October 6, 2015.
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 | K152948 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2015 |
| Decision Date | February 04, 2016 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| 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. |