COOL CUT— 510(k) K931429

Substantially Equivalent

Mitab

FDA 510(k) clearance K931429 for COOL CUT, Substantially Equivalent on 1994-04-29. Applicant: Mitab.

Clearance details

Applicant: Mitab
Product code: Code HWE
Advisory panel: General, Plastic Surgery
Date received: 1993-03-22
Decision date: 1994-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

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.