COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES— 510(k) K933768

Substantially Equivalent

Mahe-Medizintechnik

FDA 510(k) clearance K933768 for COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES, Substantially Equivalent on 1994-06-27. Applicant: Mahe-Medizintechnik.

Clearance details

Applicant: Mahe-Medizintechnik
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 1993-07-29
Decision date: 1994-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

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Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

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.