K190512 is an FDA 510(k) clearance for the SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare. This device is classified as a Snare, Flexible (Class II - Special Controls, product code FDI).
Submitted by Intelligent Endoscopy (Clemmons, US). The FDA issued a Cleared decision on November 22, 2019, 266 days after receiving the submission on March 1, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4300.
| 510(k) Number | K190512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2019 |
| Decision Date | November 22, 2019 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDI - Snare, Flexible |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4300 |