Accurett— 510(k) K161615

Substantially Equivalent

H&O Equipments, Nv/Sa

FDA 510(k) clearance K161615 for Accurett, Substantially Equivalent on 2016-08-23. Applicant: H&O Equipments, Nv/Sa.

Clearance details

Applicant: H&O Equipments, Nv/Sa
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2016-06-10
Decision date: 2016-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Ghislenghien, BE

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

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.