510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941325Substantially Equivalent

Water Irrigator, W1 200

Strong Medical, Inc., Heraklion, GR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941325 is the FDA 510(k) clearance record for WATER IRRIGATOR, W1 200, a class I device, cleared for Strong Medical, Inc. on under FDA product code KHH (Stimulator, Caloric-Air). FDA records list one 510(k) clearance for Strong Medical, Inc. As of , FDA records show no recalls naming K941325.

Clearance record

Decision date
Received
(144 days to decision)
Product code
KHH Stimulator, Caloric-Air
Regulation
21 CFR 874.1800
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Strong Medical, Inc. St. X, Industrial Area, Heraklion, GR
510(k) summary
Statement
Third party review
No

Clearances, product code KHH

Trailing 12 months

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

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