K990519 is an FDA 510(k) clearance for the PHOENIX EPIDURAL & SPINAL NEEDLES. This device is classified as a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II - Special Controls, product code BSP).
Submitted by Myco Medical Supplies, Inc. (Cary, US). The FDA issued a Cleared decision on June 2, 2000, 470 days after receiving the submission on February 18, 1999.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K990519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 1999 |
| Decision Date | June 02, 2000 |
| Days to Decision | 470 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BSP - Needle, Conduction, Anesthetic (w/wo Introducer) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5150 |