K221293 is an FDA 510(k) clearance for the E-Brik Visualization Assistant. This device is classified as a Anti Fog Solution And Accessories, Endoscopy (Class II - Special Controls, product code OCT).
Submitted by Jdi Surgical, Inc. (Highlands Ranch, US). The FDA issued a Cleared decision on July 7, 2022, 64 days after receiving the submission on May 4, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 876.1500. To Prevent, Reduce Or Eliminate Condensation (fog) On Endoscopic Lens..
| 510(k) Number | K221293 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2022 |
| Decision Date | July 07, 2022 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| 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. |