K192349 is an FDA 510(k) clearance for the Bactisure Wound Lavage. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Next Science, LLC (Jacksonsonville, US). The FDA issued a Cleared decision on January 23, 2020, 147 days after receiving the submission on August 29, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K192349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2019 |
| Decision Date | January 23, 2020 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FQH - Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |