MAHE INSTRUMENTS— 510(k) K942821

Substantially Equivalent

Mahe-Medizintechnik

FDA 510(k) clearance K942821 for MAHE INSTRUMENTS, Substantially Equivalent on 1994-11-02. Applicant: Mahe-Medizintechnik.

Clearance details

Applicant: Mahe-Medizintechnik
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1994-06-14
Decision date: 1994-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, 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.