OXYTEC, MODEL 900— 510(k) K043615

Substantially Equivalent

Oxytec Medical Corporation

FDA 510(k) clearance K043615 for OXYTEC, MODEL 900, Substantially Equivalent on 2005-02-09. Applicant: Oxytec Medical Corporation.

Clearance details

Applicant: Oxytec Medical Corporation
Product code: Code CAW
Advisory panel: Anesthesiology
Date received: 2004-12-30
Decision date: 2005-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mccordsville, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAW

product code CAW

Death: 204
Injury: 573
Malfunction: 1,400
Other: 6
Total: 2,183

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.