FDA 510(k) clearance · back to tracker

Manual Tissue Removal Device

Suzhou AcuVu Medical Technology Co., Ltd. cleared K254050 on 2026-05-15, decision: substantially equivalent

K-number

K254050

Sponsor

Suzhou AcuVu Medical Technology Co., Ltd.

Device

Manual Tissue Removal Device

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-15

Product code

HIH

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.1690

Official FDA record

Open K254050on 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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Raw record →

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.