Endocyte, Disposable Endometrial Sampler

FDA 510(k) K881220 · Laboratoire Ccd C/O Washington Regulatory Services

Substantially Equivalent

510(k) numberK881220

Submission

Device name
Endocyte, Disposable Endometrial Sampler
Applicant
Laboratoire Ccd C/O Washington Regulatory Services
Ringoes, NJ, US
Received
March 22, 1988
Decision date
June 14, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HFE – Brush, Endometrial
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1100
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HFE

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K240595Utepreva Endometrial Sampler (UP01)HFE · Traditional Utepreva, LLC08/14/2024SE
K170603Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional Cook Incorporated05/24/2017SE
K112763Matrixbrush Endometrial SamplerHFE · Traditional Post Oak Innovations, Inc.06/18/2012SE
K082066Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional Cook Urological, Inc.11/07/2008SE
K941298Iumc Endometrial SamplerHFE · Traditional Cook Ob/Gyn02/13/1995SE
K911620Stovall Endometrial BrushHFE · Traditional Cook Ob/Gyn06/24/1994SE
K897070Endobrush(Tm) Device; OmnibrushHFE · Traditional Intl. Cytobrush, Inc.09/10/1990SE
K843941EndocyteHFE · Traditional Gyneco, Inc.02/25/1985SE

More from Gyneco, Inc.

510(k)DeviceDecision
K890706CytobrushHHT · Traditional 04/25/1989SE
K884696Resubmitted Artificial Insemination Instrument SetHDR · Traditional 01/27/1989SE
K881456Pipelle de Cornier Endometrial Suction CuretteHHK · Traditional 10/14/1988SE

Questions and answers

When was Endocyte, Disposable Endometrial Sampler cleared by the FDA?

Endocyte, Disposable Endometrial Sampler (K881220) received a 510(k) decision of Substantially Equivalent on June 14, 1988, 84 days after the submission was received.

What is the product code of K881220?

The FDA product code is HFE – Brush, Endometrial, a Class II (moderate risk) device regulated under 21 CFR 884.1100.