K161323 is an FDA 510(k) clearance for the Solution Set for Epidural Use. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Baxter Healthcare Corporation (Round Lake, US). The FDA issued a Cleared decision on November 30, 2016, 203 days after receiving the submission on May 11, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K161323 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2016 |
| Decision Date | November 30, 2016 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |