K192914 is an FDA 510(k) clearance for the Stimuplex Onvision System. This device is classified as a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II - Special Controls, product code BSP).
Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on May 27, 2020, 225 days after receiving the submission on October 15, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K192914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2019 |
| Decision Date | May 27, 2020 |
| Days to Decision | 225 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 |