Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)— 510(k) K260264
Substantially EquivalentShanghai Medi Astro Technology Co., Ltd.
FDA 510(k) clearance K260264 for Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON), Substantially Equivalent on 2026-10-14. Applicant: Shanghai Medi Astro Technology Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shanghai Medi Astro Technology Co., Ltd.
- Product code
- Product code ETA
- Device class
- Class 2
- Regulation
- 21 CFR 874.3495
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code ETA
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- K091187 — GRACE DYNAMIC TORP
- K083780 — SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
- K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES
Data sourced from openFDA. This site is unofficial and independent of the FDA.