510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982731Substantially Equivalent

Merogel Nasal Dressing and Sinus Stent

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

K982731 is the FDA 510(k) clearance record for MEROGEL NASAL DRESSING AND SINUS STENT, a class I device, cleared for Xomed, Inc. on under FDA product code EMX (Balloon, Epistaxis). FDA records list 46 510(k) clearances for Xomed, Inc., from to . As of , FDA records show no recalls naming K982731.

Clearance record

Decision date
Received
(181 days to decision)
Product code
EMX Balloon, Epistaxis
Regulation
21 CFR 874.4100
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Xomed, Inc. 6743 Southpoint Dr. N., Jacksonville FL
510(k) summary
Summary
Third party review
No

Clearances, product code EMX

Trailing 12 months

FDA records hold no clearances under product code EMX in the trailing twelve months.

FDA records show no clearances under product code EMX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EMX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260