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510(k) K260264

Device
Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON)
Applicant
Shanghai Medi Astro Technology Co., Ltd.
510(k) number
K260264
Product code
ETA
Decision
Substantially Equivalent (SESE)
Decision date
2026-10-14
Date received
2026-01-28
Regulation
874.3495
Classification name
Replacement, Ossicular Prosthesis, Total
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Bingbing Jie
Address
Rm. 1001, Bldg. 1 # 98, Fulian 1st Rd., Baoshan District Shanghai CN 201906 201906

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ETA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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 GmbH2026-04-03
K241269mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis KitMED-EL Elektromedizinische Geräte GmbH2025-01-17
K091187GRACE DYNAMIC TORPGrace Medical, Inc.2009-09-14
K083780SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2Audio Technologies S.R.L.2009-03-23
K043375FISCH TITANIUM MIDDLE EAR PROSTHESESKarl Storz Endoscopy2005-01-24
K042503KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik2004-10-01
K030492TITANIUM OSSICULAR REPLACMENT SYSTEMInvotec International, Inc.2003-03-03
K002378MODULAR PORP AND TORP MODEL TBDGyrus Ent LLC2000-08-29
K001404GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTONMednet Locator, Inc.2000-08-08
K001406HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESESMednet Locator, Inc.2000-08-08
K001902BOJRAB UNIVERSAL LONG IMLANT, MODEL TBDGyrus Ent LLC2000-07-10
K993583ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEMStryker Corp.1999-11-10
K992138MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIESMicromedics, Inc.1999-08-09
K990601BOJRAB MICRO-TORP, MODEL 7014-5845Gyrus Ent LLC1999-03-31
K981088MILLS COLUMELLA PROSTHESISExmoor Plastics , Ltd.1998-06-05