K971342

Substantially Equivalent

DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)

Applicant: Disk Whisk, Inc.
Product code: HWE
Advisory panel: General, Plastic Surgery
Date received: 1997-04-10
Decision date: 1997-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Adverse events under product code HWE

product code HWE

Death: 4
Injury: 448
Malfunction: 19,856
Other: 2
Total: 20,310

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.