K243001 is an FDA 510(k) clearance for the Sterile Water USP and Sterile 0.9% Normal Saline USP. This device is classified as a Dressing, Wound, Drug.
Submitted by Laboratorios Biogalenic S.A. DE C.V. (San Salvador, SV). The FDA issued a Cleared decision on March 6, 2025, 161 days after receiving the submission on September 26, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K243001 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2024 |
| Decision Date | March 06, 2025 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO - Dressing, Wound, Drug |
| Device Class | - |