Medevices Aspiration Hose

FDA 510(k) K823006 · Berkeley Medevices

Substantially Equivalent

510(k) numberK823006

Submission

Device name
Medevices Aspiration Hose
Applicant
Berkeley Medevices
Mchenry, IL, US
Received
October 12, 1982
Decision date
November 4, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HHK – Curette, Suction, Endometrial (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1175
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HHK

510(k)DeviceApplicantDecision
K251882Uterine Aspiration SetHHK · Traditional Gcmedica Enterprise Ltd.(Wuxi)10/16/2025SE
K240434RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)HHK · Traditional Li Medical Corporation , Ltd.09/25/2024SE
K201952CrossGlide ETS PlusHHK · Special Crossbay Medical08/05/2020SE
K192534CrossBay Endometrial Tissue Sampler (ETS)HHK · Traditional Crossbay Medical03/25/2020SE
K102847Disposable Endometrial Suction CuretteHHK · Traditional Jiangsu Suyun Medical Materials Co., Ltd.04/14/2011SE
K092982The Panpac Suction CuretteHHK · Traditional Panpac Medical Corporation07/26/2010SE
K051294Femtest Endometrial Suction Curette, Model FT-1HHK · Traditional Femspec LLC12/21/2005SE
K040189Endometrial Sampling SyringeHHK · Traditional Rocket Medical Plc10/04/2004SE
K021876Mas with or Without SyringeHHK · Traditional Marina Medical Instruments, Inc.04/08/2003SE
K020628Curelle, Preferred Curelle, Cuteq 2.5HHK · Traditional Bioteque America, Inc.05/24/2002SE

More from Bioteque America, Inc.

510(k)DeviceDecision
K892220Laminaria TentHDY · Traditional 06/14/1989SE
K840952Medevice V-80 Vacuum PumpHHI · Traditional 03/30/1984SE
K812389Surgical LoopsGAD · Traditional 11/16/1981SE
K812388Surgical PawsGDJ · Traditional 11/16/1981SE

Questions and answers

When was Medevices Aspiration Hose cleared by the FDA?

Medevices Aspiration Hose (K823006) received a 510(k) decision of Substantially Equivalent on November 4, 1982, 23 days after the submission was received.

What is the product code of K823006?

The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.