FDA 510(k) clearance · back to tracker

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

Zhejiang Curaway Medical Technology Co., Ltd. cleared K222001 on 2023-06-08, decision: substantially equivalent

K-number

K222001

Sponsor

Zhejiang Curaway Medical Technology Co., Ltd.

Device

Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

Class

Class II

Decision

Substantially Equivalent

Decision date

2023-06-08

Product code

OAB

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K222001on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.