Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018)— 510(k) K232241

Substantially Equivalent

Betters(Suzhou) Medical Co., Ltd.

FDA 510(k) clearance K232241 for Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018), Substantially Equivalent on 2023-11-13. Applicant: Betters(Suzhou) Medical Co., Ltd..

Clearance details

Applicant: Betters(Suzhou) Medical Co., Ltd.
Product code: Code NEY
Advisory panel: General, Plastic Surgery
Date received: 2023-07-28
Decision date: 2023-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEY

product code NEY

Death: 24
Injury: 388
Malfunction: 462
Other: 1
Total: 875

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.