K211085 is an FDA 510(k) clearance for the BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle. This device is classified as a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II - Special Controls, product code BSP).
Submitted by Becton, Dickinson and Company (Franklin Lakes, US). The FDA issued a Cleared decision on July 1, 2022, 445 days after receiving the submission on April 12, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K211085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2021 |
| Decision Date | July 01, 2022 |
| Days to Decision | 445 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSP — Needle, Conduction, Anesthetic (w/wo Introducer) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5150 |