Cleared Traditional

K083780 - SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2

K083780 is an FDA 510(k) clearance for SUPERELELASTIC NITINOL PISTON, manufactured by Audio Technologies S.R.L.. The device is a Class 2 Ear, Nose, Throat device with product code ETA cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K083780 · Audio Technologies S.R.L. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
94d
Days
Class 2
Risk

K083780 is an FDA 510(k) clearance for the SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL S.... Classified as Replacement, Ossicular Prosthesis, Total (product code ETA), Class II - Special Controls.

Submitted by Audio Technologies S.R.L. (Piacenza, IT). The FDA issued a Cleared decision on March 23, 2009 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3495 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Audio Technologies S.R.L. devices

FDA 510(k) Submission Details - K083780

510(k) Number K083780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2008
Decision Date March 23, 2009
Days to Decision 94 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 90d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETA Device Classification - Class 2, Special Controls

Product Code ETA Replacement, Ossicular Prosthesis, Total
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3495
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETA Replacement, Ossicular Prosthesis, Total

All 26
Devices cleared under the same product code (ETA) and FDA review panel - the closest regulatory comparables to K083780.
mGRIP Total Prosthesis (3.00 mm) (58689)
K260719 · Med-El Elektromedizinische Ger?te GmbH · Apr 2026
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit
K241269 · Med-El Elektromedizinische Ger?te GmbH · Jan 2025
GRACE DYNAMIC TORP
K091187 · Grace Medical, Inc. · Sep 2009
FISCH TITANIUM MIDDLE EAR PROSTHESES
K043375 · Karl Storz Endoscopy · Jan 2005
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
K042503 · Heinz Kurz GmbH Medizintechnik · Oct 2004
TITANIUM OSSICULAR REPLACMENT SYSTEM
K030492 · Invotec International, Inc. · Mar 2003