ZOOM Aspiration Pump— 510(k) K190105

Substantially Equivalent

Taiwan Biomaterial Co., Ltd.

FDA 510(k) clearance K190105 for ZOOM Aspiration Pump, Substantially Equivalent on 2019-02-21. Applicant: Taiwan Biomaterial Co., Ltd..

Clearance details

Applicant: Taiwan Biomaterial Co., Ltd.
Product code: Code JCX
Advisory panel: General, Plastic Surgery
Date received: 2019-01-22
Decision date: 2019-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Zhubei, 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.