FDA 510(k) clearance · back to tracker

Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)

Shanghai Medi Astro Technology Co., Ltd. cleared K260264 on 2026-10-14, decision: substantially equivalent

K-number

K260264

Sponsor

Shanghai Medi Astro Technology Co., Ltd.

Device

Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-14

Product code

ETA

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.3495

Official FDA record

Open K260264on 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.