TECHDEVICE GUIDEWIRE— 510(k) K053028

Substantially Equivalent

Techdevice Corporation

FDA 510(k) clearance K053028 for TECHDEVICE GUIDEWIRE, Substantially Equivalent on 2006-01-31. Applicant: Techdevice Corporation.

Clearance details

Applicant: Techdevice Corporation
Product code: Code OCY
Advisory panel: Gastroenterology, Urology
Date received: 2005-10-27
Decision date: 2006-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCY

product code OCY

Injury: 186
Malfunction: 578
Total: 764

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.