K022777

Substantially Equivalent

MANUAL TOUCHE SYSTEM

Applicant: Onux Medical, Inc.
Product code: GAQ
Advisory panel: General, Plastic Surgery
Date received: 2002-08-21
Decision date: 2002-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hampton, NH, US

Adverse events under product code GAQ

product code GAQ

Death: 3
Malfunction: 522
Total: 525

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.