DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)— 510(k) K971342

Substantially Equivalent

Disk Whisk, Inc.

FDA 510(k) clearance K971342 for DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD), Substantially Equivalent on 1997-07-08. Applicant: Disk Whisk, Inc..

Clearance details

Applicant: Disk Whisk, Inc.
Product code: 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

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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.