510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821481Substantially Equivalent

Nasal-Throat Spray Irrigation Instrum.

Ethicare Products, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821481 is the FDA 510(k) clearance record for NASAL-THROAT SPRAY IRRIGATION INSTRUM., a class I device, cleared for Ethicare Products on under FDA product code ETP (Stimulator, Caloric-Water). FDA records list one 510(k) clearance for Ethicare Products. As of , FDA records show no recalls naming K821481.

Clearance record

Decision date
Received
(27 days to decision)
Product code
ETP Stimulator, Caloric-Water
Regulation
21 CFR 874.1800
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Ethicare Products 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code ETP

Trailing 12 months

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

FDA records show no clearances under product code ETP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ETP, 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