510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954491Substantially Equivalent

Hydrocell Nasal and Sinus Packs

Smith & Nephew Richards, Inc., Bartlett TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954491 is the FDA 510(k) clearance record for HYDROCELL NASAL AND SINUS PACKS, a class I device, cleared for Smith & Nephew Richards, Inc. on under FDA product code EMX (Balloon, Epistaxis). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K954491.

Clearance record

Decision date
Received
(49 days to decision)
Product code
EMX Balloon, Epistaxis
Regulation
21 CFR 874.4100
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Smith & Nephew Richards, Inc. 2925 Appling Rd., Bartlett TN
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