Pipelle de Cornier Endometrial Suction Curette

FDA 510(k) K881456 · Laboratoire Ccd C/O Washington Regulatory Services

Substantially Equivalent

510(k) numberK881456

Submission

Device name
Pipelle de Cornier Endometrial Suction Curette
Applicant
Laboratoire Ccd C/O Washington Regulatory Services
Ringoes, NJ, US
Received
April 6, 1988
Decision date
October 14, 1988
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
K890706CytobrushHHT · Traditional 04/25/1989SE
K884696Resubmitted Artificial Insemination Instrument SetHDR · Traditional 01/27/1989SE
K881220Endocyte, Disposable Endometrial SamplerHFE · Traditional 06/14/1988SE

Questions and answers

When was Pipelle de Cornier Endometrial Suction Curette cleared by the FDA?

Pipelle de Cornier Endometrial Suction Curette (K881456) received a 510(k) decision of Substantially Equivalent on October 14, 1988, 191 days after the submission was received.

What is the product code of K881456?

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