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Disposable Microwave Ablation Needle (T-1408 +7 more)

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 (T-1408 +7 more) 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