510(k) K895756— MIKRO-AQUAPURATOR

Substantially Equivalent

Mikro-Tek Laboratories

Clearance details

Applicant: Mikro-Tek Laboratories
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1989-09-26
Decision date: 1989-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.