Suction Irrigator

FDA 510(k) K003443 · Applied Medical

Substantially Equivalent

510(k) numberK003443

Submission

Device name
Suction Irrigator
Applicant
Applied Medical
Rancho Santa, CA, US
Received
November 6, 2000
Decision date
February 1, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FHF – System, Evacuator, Fluid
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4370
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FHF

510(k)DeviceApplicantDecision
K093479Disposable Suction and Irrigation SystemFHF · Traditional Modern Medical Equipment Mfg., Ltd.05/19/2010SE
K771986Catheter, Mediastinal&PericardialFHF · Traditional The Minnesota Back Brace Co.10/28/1977SE

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Questions and answers

When was Suction Irrigator cleared by the FDA?

Suction Irrigator (K003443) received a 510(k) decision of Substantially Equivalent on February 1, 2001, 87 days after the submission was received.

What is the product code of K003443?

The FDA product code is FHF – System, Evacuator, Fluid, a Class II (moderate risk) device regulated under 21 CFR 876.4370.