VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE— 510(k) K060782

Substantially Equivalent

Smith & Nephew Wound Management

FDA 510(k) clearance K060782 for VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE, Substantially Equivalent on 2006-04-12. Applicant: Smith & Nephew Wound Management.

Clearance details

Applicant: Smith & Nephew Wound Management
Product code: Code FQH
Advisory panel: General Hospital
Date received: 2006-03-22
Decision date: 2006-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FQH

product code FQH

Injury: 170
Malfunction: 2,513
Other: 1
Total: 2,684

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.