K110958 is an FDA 510(k) clearance for the VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH. 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 August 1, 2011, 118 days after receiving the submission on April 5, 2011.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5475.
| 510(k) Number | K110958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2011 |
| Decision Date | August 01, 2011 |
| Days to Decision | 118 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 |