Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004542960

FEI Number

3004542960

Entity Name

MAUNA KEA TECHNOLOGIES

City/State/Country

PARIS Ile-de-France, FR

Establishment Address

9, RUE D ENGHIEN, PARIS Ile-de-France F-75010, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mauna Kea Technologies (Owner Number: 9074201)

Owner / Operator Contact Address

9, RUE D'ENGHIEN, --, PARIS, FR-IDF F-75010, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111047

PMA Number

N/A

All Registered Proprietary Names

Cellvizio 100 Series Systems with Confocal Miniprobes Cellvizio 100 Series with Confocal Miniprobes CelioFlex UHD 5 UROFLEX B CYSTOFLEX F GastroFlex M Confocal Miniprobe Cellvizio 100 Series Cellvizio 100 Series System with Confocal Miniprobes AlveoFlex M Confocal Miniprobe GastroFlex M Confocal Miniprobe Cellvizio 100 Series CranioFlex CranioFlex-C UroFlex B-C CystoFlex F-C AQ-Flex 19 -C CholangioFlex -C Cellvizio® 100 Series with Confocal Miniprobes¿

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2018-07-06
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2018-07-06
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2019-12-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-12-04
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2016-07-08
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2014-11-17
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2012-12-21
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2017-11-10
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2012-12-21
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2018-08-08
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2018-08-08
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2022-11-15
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2022-11-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-11-15
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2011-08-19

Official Correspondent

Emmanuel Prades

US Agent Details

MICHAEL A. DANIEL Email: madaniel@clinregconsult.com Phone: (775) 3922970

Related Public Records

Same Entity

Mauna Kea Technologies

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
K191144	Mauna Kea Technologies	Cellvizio 100 Series System with Confocal Miniprobes	2020-01-24
K260108	Stryker Endoscopy	L12 LED Light Source with AIM	2026-02-12
K243591	Optosurgical, LLC	OPTOVISION Endoscopic Light Source Unit	2025-02-19
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.

Similar Registrations

Registration Number	Establishment Name	Location
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3010177712	FIBERTECH CO., LTD.	Sakura-shi Chiba, JP
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004542960. Last updated year: 2026. Please use registration number 3004542960 when referencing this establishment in official correspondence.