Product code ETA— Ear, Nose, Throat
AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
- Classification name
- Replacement, Ossicular Prosthesis, Total
- Device class
- Class 2
- Regulation
- 21 CFR 874.3495
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 39
- First cleared
- Most recent
Market context for product code ETA
FDA has cleared devices under product code ETA between 1976 and 2026, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2009
- 2005
- 2004
- 2003
- 2000
- 1999
- 1998
- 1997
- 1995
- 1994
- 1991
- 1989
- 1987
Top applicants under product code ETA
Recent clearances under product code ETA
- K260719 — mGRIP Total Prosthesis (3.00 mm) (58689) +11 more
- K241269 — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
- 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
- K042503 — KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
- K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM
- K002378 — MODULAR PORP AND TORP MODEL TBD
- K001404 — GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTON
- K001406 — HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES
- K001902 — BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD
- K993583 — ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEM
- K992138 — MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES
- K990601 — BOJRAB MICRO-TORP, MODEL 7014-5845
- K981088 — MILLS COLUMELLA PROSTHESIS
- K972735 — TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)
- K963899 — CAUSSE UNIVERSAL OSSICULAR REPLACEMENT PROSTHESIS (ORP/1)
- K972585 — AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL DUSSELDORF, DRESDEN AERIAL PROSTHESIS, AERIAL PROSTHESIS, MODEL TUBINGEN
- K955615 — MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS
- K954518 — TREBAY TOTAL RECTANGULAR HEAD
- K952549 — RICHARDS TORP
- K950927 — HAPEX MALLEABLE TORP
- K945106 — MICROMED TOTAL REGULAR AND PARTIAL OFFSET
- K934107 — BLACK OVAL-TOP TORP/PORP
- K913286 — H/A TOTAL-REGULAR, H/A TOTAL-OFFSET
- K911583 — IONOS(R) OSSICLE 5MM & 7MM
- K904239 — SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
- K895815 — MICROTEK TOTAL OSSICULAR PROTHESIS
- K884884 — OSSICULAR PROSTHESIS: 8 PARTIAL, 3 TOTAL
- K885201 — OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT
- K864444 — SHEA CUPPED TORP WITH HYDROXYLAPATITE FLANGE
- K864443 — EGG-TOP TORP AND EGG-TOP PORP
- K843461 — BIOGLASS OSSICULAR RECONSTRUCTION PROSTH
- K823912 — AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
- K823917 — PARTIAL OSSICULAR REPLACEMENT
- K823918 — AUSTIN MODIFIED PARTIAL OSSICULAR RE-
- K823919 — TOTAL OSSICULAR REPLACEMENT
- K810707 — CERAVITAL CERAMIC OSSICULAR REPL. PROS.
- K760433 — SHEA TORP, OTOLOGY IMPLANT
Data sourced from openFDA. This site is unofficial and independent of the FDA.