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FCK — Instrument, Biopsy, Suction Class II

FDA Device Classification

Classification Details

Product Code
FCK
Device Class
Class II
Regulation Number
876.1075
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K153763wilson-cook medicalHowell Biliary Aspiration NeedleApril 6, 2017
K103326united states endoscopy groupMULTIPLE BIOPSY SYSTEMApril 6, 2011
K062159aus systems ptyRB12 SUCTION RECTAL BIOPSY SYSTEMSeptember 5, 2006
K061201united states endoscopy groupDSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087May 30, 2006
K051637united states endoscopy groupDSNARE, MODEL 00711087October 31, 2005
K954693united states endoscopy groupMEHTA BRONCHIAL BIOSPY DRILLOctober 23, 1995
K944252biopsys medicalBIOPSY DEVICE ACCESSORYDecember 5, 1994
K932142triton technologySUCTION GUILLOTINE DEVICESeptember 24, 1993
K911448triton technologyMULTIPLE BIOPSY DEVICE-MBXApril 16, 1991
K902910h and b medical technologyCYTOASPIRATORJanuary 16, 1991
K902097medical measurementsMODEL TR RECTAL SUCTION BIOPSY TUBEJuly 27, 1990
K895420mill-rose laboratorySUCTION BIOPSY INSTRUMENTFebruary 9, 1990
K895900wilson-cook medicalWILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLEJanuary 11, 1990