Cytoaspirator

FDA 510(k) K902910 · H & B Medical Technology, Inc.

Substantially Equivalent

510(k) numberK902910

Submission

Device name
Cytoaspirator
Applicant
H & B Medical Technology, Inc.
Norman, OK, US
Received
July 2, 1990
Decision date
January 16, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FCK – Instrument, Biopsy, Suction
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1075
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FCK

510(k)DeviceApplicantDecision
K153763Howell Biliary Aspiration NeedleFCK · Traditional Wilson-Cook Medical, Inc.04/06/2017SE
K103326Multiple Biopsy SystemFCK · Traditional United States Endoscopy Group, Inc.04/06/2011SE
K062159RB12 Suction Rectal Biopsy SystemFCK · Traditional Aus Systems Pty , Ltd.09/05/2006SE
K061201Dsnare Diminutive Polypectomy and Suction System, Model 00711087FCK · Special United States Endoscopy Group, Inc.05/30/2006SE
K051637Dsnare, Model 00711087FCK · Traditional United States Endoscopy Group, Inc.10/31/2005SE
K954693Mehta Bronchial Biospy DrillFCK · Traditional United States Endoscopy Group, Inc.10/23/1995SE
K944252Biopsy Device AccessoryFCK · Traditional Biopsys Medical, Inc.12/05/1994SE
K932142Suction Guillotine DeviceFCK · Traditional Triton Technology, Inc.09/24/1993SE
K911448Multiple Biopsy Device-MbxFCK · Traditional Triton Technology, Inc.04/16/1991SE
K902097Model TR Rectal Suction Biopsy TubeFCK · Traditional Medical Measurements, Inc.07/27/1990SE

Questions and answers

When was Cytoaspirator cleared by the FDA?

Cytoaspirator (K902910) received a 510(k) decision of Substantially Equivalent on January 16, 1991, 198 days after the submission was received.

What is the product code of K902910?

The FDA product code is FCK – Instrument, Biopsy, Suction, a Class II (moderate risk) device regulated under 21 CFR 876.1075.