Product code FCK— Gastroenterology, Urology

FDA has cleared 13 devices under product code FCK between 1990 and 2017, filed by 8 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20171 clearance
• 20111 clearance
• 20062 clearances
• 20051 clearance
• 19951 clearance
• 19941 clearance
• 19931 clearance
• 19912 clearances
• 19903 clearances

• United States Endoscopy Group, Inc.4 clearances
• Wilson-Cook Medical, Inc.2 clearances
• Triton Technology, Inc.2 clearances
• Mill-Rose Laboratory1 clearance
• Medical Measurements, Inc.1 clearance
• H & B Medical Technology, Inc.1 clearance
• Biopsys Medical, Inc.1 clearance
• Aus Systems Pty , Ltd.1 clearance

• K153763 — Howell Biliary Aspiration NeedleWilson-Cook Medical, Inc.·2017-04-06
• K103326 — MULTIPLE BIOPSY SYSTEMUnited States Endoscopy Group, Inc.·2011-04-06
• K062159 — RB12 SUCTION RECTAL BIOPSY SYSTEMAus Systems Pty , Ltd.·2006-09-05
• K061201 — DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087United States Endoscopy Group, Inc.·2006-05-30
• K051637 — DSNARE, MODEL 00711087United States Endoscopy Group, Inc.·2005-10-31
• K954693 — MEHTA BRONCHIAL BIOSPY DRILLUnited States Endoscopy Group, Inc.·1995-10-23
• K944252 — BIOPSY DEVICE ACCESSORYBiopsys Medical, Inc.·1994-12-05
• K932142 — SUCTION GUILLOTINE DEVICETriton Technology, Inc.·1993-09-24
• K911448 — MULTIPLE BIOPSY DEVICE-MBXTriton Technology, Inc.·1991-04-16
• K902910 — CYTOASPIRATORH & B Medical Technology, Inc.·1991-01-16
• K902097 — MODEL TR RECTAL SUCTION BIOPSY TUBEMedical Measurements, Inc.·1990-07-27
• K895420 — SUCTION BIOPSY INSTRUMENTMill-Rose Laboratory·1990-02-09
• K895900 — WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLEWilson-Cook Medical, Inc.·1990-01-11