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510(k) K032092

Device
OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE
Applicant
OLYMPUS OPTICAL CO., LTD.
510(k) number
K032092
Product code
FCL  
Decision
Substantially Equivalent (SESE)
Decision date
2003-07-16
Date received
2003-07-07
Regulation
876.1075
Classification name
Forceps, Biopsy, Non-electric
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
MASAO WADA
Address
34-3 Hirai, Hinode-Machi Nishitama-Gun Tokyo JP 190-0182 190-0182

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FCL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973611SPECTRASCIENCE REUSABLE BIOPSY FORCEPSSpectrascience, Inc.1997-12-02
K971315AUXILIARY INSTRUMENTS FOR URSRichard Wolf Medical Instruments Corp.1997-09-15
K964120INJECTO FLUSHRobert J. Jynch, Jr.1996-12-30
K963517SPECTRA SCIENCE BIOPSY FORCEPSSpectrascience, Inc.1996-12-02
K955065OLYMPUS FB SERIES BIOPSY FORCEPSOlympus America, Inc.1996-01-24
K952863FORCEPS, BIOPSY, NON-ELECTRICAnnex Medical, Inc.1995-07-19
K952391DYNABITE UROLOGICAL FORCEPSPortlyn Corp.1995-06-01
K951048RITE-BITE BIOPSY FORCEPSMill-Rose Laboratory1995-03-15
K946360MODULAR BIOPSY FORCEPCox Medical Ent., Inc.1995-03-06
K950559DIENER RETRIEVAL DEVICESMill-Rose Laboratory1995-02-16
K946238SYMBIOSIS GASTROINTESTINAL BIOPSY FORCEPSSymbiosis Corp.1995-01-20
K944770LSVP INTERNATIONAL BIOPSY FORCEPSLsvp Intl., Inc.1994-10-13
K941816EMC FLEXIBLE BIOPSY FORCEPSEnterprise Medical Corp.1994-07-13
K941359GIP/MEDI-GLOBE BIOPSY FORCEPSMedi-Globe Corp.1994-07-12
K933135DAWN DISPOSABLE BIOPSY FORCEPSDawn Medical1994-03-07

Legacy Summary#

summary

FDA Review#

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