K001496 is an FDA 510(k) clearance for the A.V. FISTULA NEEDLE. This device is classified as a Needle, Fistula (Class II - Special Controls, product code FIE).
Submitted by Exelint International, Co. (Los Angeles, US). The FDA issued a Cleared decision on August 1, 2000, 78 days after receiving the submission on May 15, 2000.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5540.
| 510(k) Number | K001496 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2000 |
| Decision Date | August 01, 2000 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FIE - Needle, Fistula |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5540 |