510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003443Substantially Equivalent

Suction Irrigator

Applied Medical, Rancho Santa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003443 is the FDA 510(k) clearance record for SUCTION IRRIGATOR, a class II device, cleared for Applied Medical on under FDA product code FHF (System, Evacuator, Fluid). FDA records list 14 510(k) clearances for Applied Medical, from to . As of , FDA records show no recalls naming K003443.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FHF System, Evacuator, Fluid
Regulation
21 CFR 876.4370
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Applied Medical 22872 Avenida Empresa, Rancho Santa CA
510(k) summary
Summary
Third party review
No

Clearances, product code FHF

Trailing 12 months

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

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