510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K872112Substantially Equivalent

Xomed Platinum Wire Teflon Pistion

Xomed, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K872112 is the FDA 510(k) clearance record for XOMED PLATINUM WIRE TEFLON PISTION, a class II device, cleared for Xomed, Inc. on under FDA product code ETB (Prosthesis, Partial Ossicular Replacement). FDA records list 46 510(k) clearances for Xomed, Inc., from to . As of , FDA records show no recalls naming K872112.

Clearance record

Decision date
Received
(31 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
Xomed, Inc. 6743 Southpoint Dr. N., Jacksonville FL
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