Submission Details
| 510(k) Number | K220964 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 01, 2022 |
| Decision Date | May 16, 2023 |
| Days to Decision | 410 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
Cleared
Traditional
VERSAJET Hydrosurgery System (III)
May 2023
Decision
410d
Days
Class 2
Risk
About This 510(k) Submission
K220964 is an FDA 510(k) clearance for the VERSAJET Hydrosurgery System (III), a Lavage, Jet (Class II — Special Controls, product code FQH), submitted by Smith & Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on May 16, 2023, 410 days after receiving the submission on April 1, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5475.
Device Classification
| Product Code | FQH — Lavage, Jet |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5475 |
Manufacturer
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