Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008386005

FEI Number

3008386005

Entity Name

IAN JAMIESON PTY LTD

City/State/Country

Fyshwick Australian Capital Territory, AU

Establishment Address

64-68 Collie Street, Fyshwick Australian Capital Territory 2609, AU

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Ian Jamieson Pty Ltd (Owner Number: 10053388)

Owner / Operator Contact Address

64-68 Collie Street, Fyshwick, AU-ACT 2609, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K981543

PMA Number

N/A

All Registered Proprietary Names

P series ENF

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-03
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-06-03
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2018-06-03
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-05-12
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2019-05-12
FDA	Enteroscope And Accessories	Gastroenterology, Urology	Class 2	876.1500	2019-05-12
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-10-26
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-11-30
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-11-30
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2016-11-30
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2019-05-25
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-05-25
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-08-23
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2023-10-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-10-22
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-09-16
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2018-09-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-11-23
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-11-23
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2024-11-23
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2024-11-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-08-23
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2019-08-23
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-07-13
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2025-07-13
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-07-13
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2025-07-13
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-07-13
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2017-11-20
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2017-12-17
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-02-11
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2017-02-11
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2017-02-11
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-01-10
PSV	Ultrasound Bronchoscope	Radiology	Class 2	892.1550	2018-01-10
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-01-10
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2017-12-13
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2017-12-13
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2017-12-13
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2023-11-19
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-11-19
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-11-19
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-02-25
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2016-12-08
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2018-07-16
NWB	Endoscope, Accessories, Narrow Band Spectrum	Gastroenterology, Urology	Class 2	876.1500	2021-01-10
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2021-01-10
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-11-01

Official Correspondent

Ian Jamieson

US Agent Details

Gerald Goigitzer Business: Innovative Endoscopy Components LLC Email: gerald@endoscopy.md Phone: (954) 2178780

Related Public Records

Same Entity

Ian Jamieson Pty Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K220587	Olympus Medical Systems Corp.	Evis Exera III Duodenovideoscope Olympus TJF-Q190V	2022-05-11
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K904800	Olympus Corp.	SIF-SW	1991-03-27
K233321	FUJIFILM Healthcare Americas Corporation	Double Balloon Endoscope EN-840T, Over-tube TS-1214C	2024-06-13
K251204	FUJIFILM Healthcare Americas Corporation	FUJIFILM Stiffening Wire Device (SW-2000)	2025-09-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008386005. Last updated year: 2026. Please use registration number 3008386005 when referencing this establishment in official correspondence.