510(k) clearance

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

FDA 510(k) source

510(k) number

K260264

Applicant

Shanghai Medi Astro Technology Co., Ltd.

Decision date

Oct 14, 2026

Date received

Jan 28, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

ETA

Device type

Replacement, Ossicular Prosthesis, Total

Device class

Class II

Regulation

21 CFR 874.3495

Advisory committee

Ear, Nose, Throat

Statement or summary

Summary

Third party

N

Location

Shanghai, CN