K211212 is an FDA 510(k) clearance for the LoFric Elle. This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on February 17, 2022, 300 days after receiving the submission on April 23, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K211212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2021 |
| Decision Date | February 17, 2022 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD — Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |