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
K893134Substantially Equivalent

Apaceram Ossicular Prosthesis

Asahi Optical Co. C/O Rosati Associates, P.C., Birmingham MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893134 is the FDA 510(k) clearance record for APACERAM OSSICULAR PROSTHESIS, a class II device, cleared for Asahi Optical Co. C/O Rosati Associates, P.C. on under FDA product code ETB (Prosthesis, Partial Ossicular Replacement). FDA records list 4 510(k) clearances for Asahi Optical Co. C/O Rosati Associates, P.C., from to . As of , FDA records show no recalls naming K893134.

Clearance record

Decision date
Received
(100 days to decision)
Product code
ETB Prosthesis, Partial Ossicular Replacement
Regulation
21 CFR 874.3450
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Asahi Optical Co. C/O Rosati Associates, P.C. Attorney & Counselor At Law, Birmingham MI
Third party review
No

Clearances, product code ETB

Trailing 12 months
2 clearances under product code ETB in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ETB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260