K142564 is an FDA 510(k) clearance for the JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4). 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 December 23, 2014, 103 days after receiving the submission on September 11, 2014.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K142564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2014 |
| Decision Date | December 23, 2014 |
| Days to Decision | 103 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 |