ELAN 4 Air Motor System— 510(k) K172907

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K172907 for ELAN 4 Air Motor System, Substantially Equivalent on 2018-11-09. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code HBB
Advisory panel: Neurology
Date received: 2017-09-25
Decision date: 2018-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.