K161623 is an FDA 510(k) clearance for the Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL. This device is classified as a Dressing, Wound, Drug.
Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on November 10, 2016, 150 days after receiving the submission on June 13, 2016.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K161623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2016 |
| Decision Date | November 10, 2016 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |