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Data / Medical devices / Australia / Ian Jamieson Pty Ltd

Ian Jamieson Pty Ltd: FDA-registered device maker in Fyshwick Australian Capital Territory, Australia, 30 510(k) clearances

Ian Jamieson Pty Ltd is registered with the FDA (registration 3008386005) in Fyshwick Australian Capital Territory, Australia. It lists 26 device types. The FDA files 30 510(k) clearances under its listings, the newest dated April 26, 2023. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Ian Jamieson Pty Ltd
FDA registration number
3008386005
Address
64-68 Collie Street, Fyshwick Australian Capital Territory, Australia, 2609
Owner or operator
Ian Jamieson Pty Ltd (10053388)
Roles
Exporter to the US
First device listed
November 30, 2016
Registered through
2026
Brand names listed
P series ENF

Devices it lists

DeviceProduct codeClassRoleSource
Bronchoscope (Flexible Or Rigid)EOQ2Exporter to the USaccessdata.fda.gov
Choledochoscope And Accessories, Flexible/RigidFBN2Exporter to the USaccessdata.fda.gov
Colonoscope And Accessories, Flexible/RigidFDF2Exporter to the USaccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Exporter to the USaccessdata.fda.gov
Duodenoscope And Accessories, Flexible/RigidFDT2Exporter to the USaccessdata.fda.gov
Endoscope, Accessories, Narrow Band SpectrumNWB2Exporter to the USaccessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-UrologyFED2Exporter to the USaccessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-UrologyODG2Exporter to the USaccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Exporter to the USaccessdata.fda.gov
Enteroscope And AccessoriesFDA2Exporter to the USaccessdata.fda.gov
Forceps, Biopsy, ElectricKGE2Exporter to the USaccessdata.fda.gov
Gastroscope And Accessories, Flexible/RigidFDS2Exporter to the USaccessdata.fda.gov
Hysteroscope (And Accessories)HIH2Exporter to the USaccessdata.fda.gov
Kit, NephroscopeFGA2Exporter to the USaccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Exporter to the USaccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Exporter to the USaccessdata.fda.gov
Led Light SourceNTN2Exporter to the USaccessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)EOB2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Exporter to the USaccessdata.fda.gov
Telescope, Rigid, EndoscopicFBP2Exporter to the USaccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Exporter to the USaccessdata.fda.gov
Ultrasound BronchoscopePSV2Exporter to the USaccessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)KNS2Exporter to the USaccessdata.fda.gov
Ureteroscope And Accessories, Flexible/RigidFGB2Exporter to the USaccessdata.fda.gov
UrethroscopeFGC2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 26, 2023K222584EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100FETSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
January 20, 2023K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)FAJSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
December 29, 2022K221690OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)FAJSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
January 21, 2021K201758EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190EOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
January 16, 2019K181451URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7RFGBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
March 30, 2018K172246OLYMPUS URF-V2/V2RFGBSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
January 15, 2016K143153EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE Q180VFDTSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
November 24, 2015K151191OES ELITE Telescopes, Protective TubeFBPSubstantially EquivalentOlympus Winter & Ibe GmbHaccessdata.fda.gov
April 10, 2014K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)FDSSubstantially EquivalentPentax Medical Companyaccessdata.fda.gov
August 29, 2013K131780EVIS EXERA III VIDEO SYSTEMFDFSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
March 1, 2013K123365OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190HETSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
January 10, 2013K121959EVIS EXERA III VIDEO SYSTEMEOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
February 16, 2012K112680EVIS EXERA III VIDEO SYSTEMFDFSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
October 8, 2010K102059AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017FETSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
July 2, 2010K100584EVIS EXERAII 180 SYSTEMNWBSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
June 17, 2010K093395OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPEIYNSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
November 5, 2008K082720TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005EOQSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
March 25, 2008K071254SMALL INTESTINAL VIDEOSCOPE SYSTEMFDASubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
March 18, 2008K072957EVIS EXERA II 180 SYSTEMNWBSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
July 5, 2007K070983OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEMPSVSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
September 22, 2006K062049EVIS EXERA II 180 SYSTEMNWBSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
August 31, 2006K061313EVIS EXERA 180 SYSTEMEOQSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
October 13, 2005K051645EVIS EXERA 160A SYSTEMNWBSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
July 1, 2005K051541GF-UE160-AL5 ULTRASOUND ENDOSCOPEFDFSubstantially EquivalentOlympus America, Inc.accessdata.fda.gov
January 31, 2003K023984MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESEOQSubstantially EquivalentThe Olympus Optical Co.accessdata.fda.gov
July 25, 2001K011869XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENTEOBSubstantially EquivalentThe Olympus Optical Co.accessdata.fda.gov
May 9, 2000K001241EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/IFDFSubstantially EquivalentThe Olympus Optical Co.accessdata.fda.gov
March 30, 2000K993041OLYMPUS XCYF-1T3 OES CYSTOFIBERSCOPE/NEPHROFIBERSCOPE ACCESSORIES AND ANCILLARY EQUIPMENTFAJSubstantially EquivalentThe Olympus Optical Co.accessdata.fda.gov
June 8, 1998K981543OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENTEOQSubstantially EquivalentThe Olympus Optical Co.accessdata.fda.gov
March 29, 1996K954451EVIS 140 SYSTEMFETSubstantially EquivalentOlympus America, Inc.accessdata.fda.gov

Compare with other makers

Updated April 26, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.