Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007345416

FEI Number

3007345416

Entity Name

ENDOCONTROL

City/State/Country

La Tronche Isere, FR

Establishment Address

2 avenue de l'Obiou, La Tronche Isere 38700, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EndoControl (Owner Number: 10032195)

Owner / Operator Contact Address

6930 Carroll Ave, 10th Floor Suite 1000, Takoma Park, MD 20912, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K082233

PMA Number

N/A

All Registered Proprietary Names

ViKY EP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-04-19

Official Correspondent

David Hinds

US Agent Details

David Hinds Email: dhinds@usmedinnov.com Phone: (301) 2700147

Related Public Records

Same Entity

EndoControl

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
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

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
3016804805	CLEARCAM	Austin, TX, US
3011936016	Sony Olympus Medical Solutions Inc.	Hachioji-shi Tokyo, JP
3015335150	VERNACARE LTD.	Chorley Lancashire, GB
1221072	VASCULAR TECHNOLOGY INCORPORATED	NASHUA, NH, US
3021744308	Lazurite Inc.	Cleveland, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007345416. Last updated year: 2026. Please use registration number 3007345416 when referencing this establishment in official correspondence.