HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE— 510(k) K032969

Substantially Equivalent

Helica Instruments, Ltd.

FDA 510(k) clearance K032969 for HELICA TC LAPAROSCOPIC CUTTING AND CAUTERISING (LTC) PROBE, Substantially Equivalent on 2004-02-04. Applicant: Helica Instruments, Ltd..

Clearance details

Applicant: Helica Instruments, Ltd.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2003-09-23
Decision date: 2004-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.