K151017 is an FDA 510(k) clearance for the JMS Harmony A.V. Fistula Needle Set. This device is classified as a Needle, Fistula (Class II - Special Controls, product code FIE).
Submitted by JMS North America Corporation (Hayward, US). The FDA issued a Cleared decision on May 13, 2015, 27 days after receiving the submission on April 16, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K151017 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2015 |
| Decision Date | May 13, 2015 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FIE - Needle, Fistula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |