K212328 is an FDA 510(k) clearance for the DiscCath Needle Set. This device is classified as a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II - Special Controls, product code BSP).
Submitted by Disccath, LLC (New York, US). The FDA issued a Cleared decision on September 26, 2021, 61 days after receiving the submission on July 27, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K212328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2021 |
| Decision Date | September 26, 2021 |
| Days to Decision | 61 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 |