510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083780Substantially Equivalent

Superelelastic Nitinol Piston, Superelastic Nitinol Trimmable Piston, Model Spl03.39/40/41/42 (Details in 510(K) Annex 2

Audio Technologies S.r.l., Piacenza, IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083780 is the FDA 510(k) clearance record for SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2, a class II device, cleared for Audio Technologies S.R.L. on under FDA product code ETA (Replacement, Ossicular Prosthesis, Total). FDA records list 2 510(k) clearances for Audio Technologies S.R.L., from to . As of , FDA records show no recalls naming K083780.

Clearance record

Decision date
Received
(94 days to decision)
Product code
ETA Replacement, Ossicular Prosthesis, Total
Regulation
21 CFR 874.3495
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Audio Technologies S.R.L. Via Vallera, 42, Piacenza, IT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ETA

Trailing 12 months
1 clearance under product code ETA in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ETA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260