i-Cut— 510(k) K243821

Substantially Equivalent

A.M.I. Agency For Medical Innovations GmbH

FDA 510(k) clearance K243821 for i-Cut, Substantially Equivalent on 2025-04-25. Applicant: A.M.I. Agency For Medical Innovations GmbH.

Clearance details

Applicant: A.M.I. Agency For Medical Innovations GmbH
Product code: Code HET
Advisory panel: Obstetrics/Gynecology
Date received: 2024-12-12
Decision date: 2025-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Feldkirch, AT

Download summary PDF View on FDA.gov ↗

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.