K112178 is an FDA 510(k) clearance for the JMS APHERESIS NEEDLE SET WINGEATER(R) V2. This device is classified as a Needle, Fistula (Class II - Special Controls, product code FIE).
Submitted by JMS North America Corporation (Crofton, US). The FDA issued a Cleared decision on October 27, 2011, 91 days after receiving the submission on July 28, 2011.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K112178 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2011 |
| Decision Date | October 27, 2011 |
| Days to Decision | 91 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 |