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Disposable Microwave Ablation Needle - L-2018

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232241

by Betters(Suzhou) Medical Co., Ltd.

Identifiers

510(k) Number
K232241 FDA 510(k)
FDA Product Code
NEY FDA 510(k)
Models / Variants
T-1408 FDA 510(k)
T-1410 FDA 510(k)
T-1608 FDA 510(k)
T-1610 FDA 510(k)
L-1815 FDA 510(k)
L-1818 FDA 510(k)
L-2015 FDA 510(k)
L-2018 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Disposable Microwave Ablation Needle - L-2018 by Betters(Suzhou) Medical Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 8 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Betters(Suzhou) Medical Co., Ltd.

Sources (1)

  • FDA 510(k) K232241 24 fields · synced Jun 18, 2026