K011988

Substantially Equivalent

SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C

Applicant: Cardiofocus, Inc.
Product code: OCL
Advisory panel: General, Plastic Surgery
Date received: 2001-06-26
Decision date: 2001-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norton, MA, US

Adverse events under product code OCL

product code OCL

Death: 34
Injury: 256
Total: 290

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.