510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K043375Substantially Equivalent

Fisch Titanium Middle Ear Prostheses

Karl Storz Endoscopy-America, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043375 is the FDA 510(k) clearance record for FISCH TITANIUM MIDDLE EAR PROSTHESES, a class II device, cleared for Karl Storz Endoscopy on under FDA product code ETA (Replacement, Ossicular Prosthesis, Total). FDA records list 402 510(k) clearances for KARL STORZ ENDOSCOPY-AMERICA, INC., from to . As of , FDA records show no recalls naming K043375.

Clearance record

Decision date
Received
(47 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
Karl Storz Endoscopy 600 Corporate Pt.e, Culver City CA
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