VERSAJET Hydrosurgery System (III)— 510(k) K220964

Substantially Equivalent

Smith & Nephew Medical Limited

FDA 510(k) clearance K220964 for VERSAJET Hydrosurgery System (III), Substantially Equivalent on 2023-05-16. Applicant: Smith & Nephew Medical Limited.

Clearance details

Applicant: Smith & Nephew Medical Limited
Product code: Code FQH
Advisory panel: General Hospital
Date received: 2022-04-01
Decision date: 2023-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hull, GB

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.