510(k) K012074

Device
XBO1-824-18/19/20 BIOPSY FORCEPS
Applicant
The Olympus Optical Co.
510(k) number
K012074
Product code
OCZ
Decision
Substantially Equivalent (SESE)
Decision date
2001-09-25
Date received
2001-07-02
Regulation
876.1500
Classification name
Endoscopic Grasping/Cutting Instrument, Non-Powered
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
LAURA STORMS-TYLER
Address
Two Corporate Dr. Melville NY US 11747 11747

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OCZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K152802Grasping ForcepsMicro-Tech (Nanjing) Co., Ltd.2016-01-21
K150939Ensizor Endoscopic ScissorsSlater Endoscopy, LLC2015-06-08
K141058ENSIZOR ENDOSCOPIC SCISSORSSlater Endoscopy, LLC2014-08-01
K133736ENDOSCOPIC SUTURE CUTTERUnited States Endoscopy Group, Inc.2014-01-07
K120084ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.2012-05-30
K103688G-PROX EZ ENDOSCOPIC GRASPERUsgi Medical2011-01-14
K101298ENDOCHOICE GRASPING INSULATED AND ALIGATOR JAW FORCEPS MODEL AMHGFA, ENDOCHOICE GRASPING INSULATED AND RAT TOOTH FORCEPSEndochoice, Inc.2010-08-05
K072684MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEMMondeal North America, Inc.2008-01-04
K051276HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEMRichard Wolf Medical Instruments Corp.2005-10-28
K010412FLEXIBLE ENDOSCOPIC SCISSORSTelemed Systems, Inc.2001-04-02
K974300TELEMED SYSTEMS RETRIEVAL BASKETTelemed Systems, Inc.1997-12-19
K973071TRI TALON RETRIEVAL FORCEPSMedical Engineering Laboratory, Inc.1997-10-24
K973259K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)Medical Creative Technologies, Inc.1997-09-10