FDA 510(k) clearance · back to tracker

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)

Hygea Medical Technology Co., Ltd. cleared K233140 on 2024-01-31, decision: substantially equivalent

K-number

K233140

Sponsor

Hygea Medical Technology Co., Ltd.

Device

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-01-31

Product code

NEY

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4400

Official FDA record

Open K233140on 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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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

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