K143115 is an FDA 510(k) clearance for the The VersaJet II Hydrosurgery System. This device is classified as a Lavage, Jet (Class II - Special Controls, product code FQH).
Submitted by Smith & Nephew, Inc. (St Petersburg, US). The FDA issued a Cleared decision on July 15, 2015, 258 days after receiving the submission on October 30, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K143115 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2014 |
| Decision Date | July 15, 2015 |
| Days to Decision | 258 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5475 |