Wallaby Avenir Coil System— 510(k) K173711

Substantially Equivalent

Wallaby Medical, Inc.

FDA 510(k) clearance K173711 for Wallaby Avenir Coil System, Substantially Equivalent on 2018-05-04. Applicant: Wallaby Medical, Inc..

Clearance details

Applicant: Wallaby Medical, Inc.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2017-12-04
Decision date: 2018-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.