PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES— 510(k) K120065

Substantially Equivalent

Plaxtron Industrial (M) Sdn. Bhd.

FDA 510(k) clearance K120065 for PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES, Substantially Equivalent on 2012-04-03. Applicant: Plaxtron Industrial (M) Sdn. Bhd..

Clearance details

Applicant: Plaxtron Industrial (M) Sdn. Bhd.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2012-01-09
Decision date: 2012-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kaohsiung City, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.