K000886 is an FDA 510(k) clearance for the SPIROL EPIDURAL CATHETER. This device is classified as a Catheter, Conduction, Anesthetic (Class II - Special Controls, product code BSO).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 5, 2000, 199 days after receiving the submission on March 20, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5120.
| 510(k) Number | K000886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2000 |
| Decision Date | October 05, 2000 |
| Days to Decision | 199 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BSO — Catheter, Conduction, Anesthetic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5120 |