K131950 is an FDA 510(k) clearance for the ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET, a Needle, Fistula (Class II — Special Controls, product code FIE), submitted by Summit International Medical Technologies, Inc. (Kingston, US). The FDA issued a Cleared decision on January 16, 2015, 568 days after receiving the submission on June 27, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K131950 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 27, 2013 |
| Decision Date | January 16, 2015 |
| Days to Decision | 568 days |
| Submission Type | Traditional |
| 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 |