VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH— 510(k) K110958
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K110958 for VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH, Substantially Equivalent on 2011-08-01. Applicant: Smith & Nephew, Inc..
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code FQH
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St Petersburg, FL, US
Adverse events under product code FQH
product code FQH- Injury
- 170
- Malfunction
- 2,513
- Other
- 1
- Total
- 2,684
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.