FDA.reportPublic FDA data

510(k) K062159

Device
RB12 SUCTION RECTAL BIOPSY SYSTEM
Applicant
AUS SYSTEMS PTY LTD.
510(k) number
K062159
Product code
FCK  
Decision
Substantially Equivalent (SESE)
Decision date
2006-09-05
Date received
2006-07-28
Regulation
876.1075
Classification name
Instrument, Biopsy, Suction
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
IAN P GORDON
Address
2454 Mcmullen Booth Rd. Suite 427 Clearwater FL US 33759 33759

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FCK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153763Howell Biliary Aspiration NeedleWilson-Cook Medical, Inc.2017-04-06
K103326MULTIPLE BIOPSY SYSTEMUnited States Endoscopy Group, Inc.2011-04-06
K061201DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087United States Endoscopy Group, Inc.2006-05-30
K051637DSNARE, MODEL 00711087United States Endoscopy Group, Inc.2005-10-31
K954693MEHTA BRONCHIAL BIOSPY DRILLUnited States Endoscopy Group, Inc.1995-10-23
K944252BIOPSY DEVICE ACCESSORYBiopsys Medical, Inc.1994-12-05
K932142SUCTION GUILLOTINE DEVICETriton Technology, Inc.1993-09-24
K911448MULTIPLE BIOPSY DEVICE-MBXTriton Technology, Inc.1991-04-16
K902910CYTOASPIRATORH & B Medical Technology, Inc.1991-01-16
K902097MODEL TR RECTAL SUCTION BIOPSY TUBEMedical Measurements, Inc.1990-07-27
K895420SUCTION BIOPSY INSTRUMENTMill-Rose Laboratory1990-02-09
K895900WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLEWilson-Cook Medical, Inc.1990-01-11

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases