MRI SAFE INSTRUMENTS— 510(k) K003965

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K003965 for MRI SAFE INSTRUMENTS, Substantially Equivalent on 2001-03-16. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code GEA
Advisory panel: General, Plastic Surgery
Date received: 2000-12-22
Decision date: 2001-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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Adverse events under product code GEA

product code GEA

Malfunction: 587
Total: 587

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.