K011209 is an FDA 510(k) clearance for the MANAN SPRITACRE SPINAL NEEDLES. This device is classified as a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II - Special Controls, product code BSP).
Submitted by Manan Medical Products, Inc. (Wheeling, US). The FDA issued a Cleared decision on June 26, 2001, 68 days after receiving the submission on April 19, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K011209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2001 |
| Decision Date | June 26, 2001 |
| Days to Decision | 68 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 |