FDA 510(k)

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

K-Number: K260264 · 2026-10-14

ApplicantShanghai Medi Astro Technology Co., Ltd.

Decision Date2026-10-14

Product CodeETA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Medi Astro Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-10-14 under 510(k) number K260264. The device is classified under product code ETA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)?

Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) is a medical device that received FDA 510(k) clearance on 2026-10-14. The listed applicant is Shanghai Medi Astro Technology Co., Ltd.. The 510(k) number is K260264.

When did Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) receive FDA 510(k) clearance?

Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) received FDA 510(k) clearance on 2026-10-14, under 510(k) number K260264.

Who is the listed applicant for Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)?

The FDA 510(k) record lists Shanghai Medi Astro Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)?

The FDA product code for Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) is ETA.

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Related Devices (Code: ETA)

K260719mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50MED-EL Elektromedizinische Geräte GmbH K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbH K091187GRACE DYNAMIC TORPGrace Medical, Inc.K083780SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2Audio Technologies S.R.L.K043375FISCH TITANIUM MIDDLE EAR PROSTHESESKarl Storz Endoscopy K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.