Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615782

FEI Number

3004084693

Entity Name

SOPRO

City/State/Country

LA CIOTAT CEDEX Bouches-du-Rhone, FR

Establishment Address

ZAC ATHELIA IV, AVENUE DES GENEVRIERS, LA CIOTAT CEDEX Bouches-du-Rhone 13705, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SATELEC-ACTEON GROUP (Owner Number: 9004992)

Owner / Operator Contact Address

1001 Briggs Rd, Suite 220, Mount Laurel, NJ 08054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K012505

PMA Number

N/A

All Registered Proprietary Names

SOPRO S397 SOPRO 397 3CCD HD SOPRO S-357 VIDEO IMAGING SYSTEM SOPRO 184 Digital Endoscopy Camera SOPRO S098 Symbioz Master SOPRO S198 Symbioz Camera SOPRO S398 Symbioz Camera SOPRO S181 SOPRO 181 UBICAM SOPRO - UBICAM FULL HD - S191 SOPRO S-57 VIDEO IMAGING SYSTEM C50 INTRAORAL CAMERA D C20 INTRAORAL CAMERA SOPRO S52D DIGITAL VIDEO LAPAROSCOP DiGILAP Titanium S165 DUO Sopro PSPIX S698 Symbioz Flow PSPIX2 SOPRO 61D SOPRO 161D SOPRO S57D DIGITAL OPERATING ROOM C SOPIX 2 SOPRO S-52 ELECTRONIC VIDEO LAPAROS Sopro S-52 Digital Viedo Laparoscope SOPRO S555 INTRAORAL DENTAL CAMERA SOPRO 162 CAMERA SOPIX INSIDE, SOPIX2 INSIDE SOPIX PLUG-IN, SOPIX2 PLUG-IN Mini Dock USB2 Mini Dock U USB2 SOPRO S-41 & 41S VIDEO IMAGING SYST Sopro S-41 & S41S Video Imaging System SOPRO 281 LED LIGHT SOURCE UBILED Tubing set Laparoscopic Insufflatio Tubing w/filter laparoscopic insuff SOPRO 225 DUAL HALOGEN LIFG SOURCE SOPRO 225 Dual Halogen Light Source C50 SOPRO 67D OPERATING ROOM CAMERA SOPRO S-357 VIDEO IMAGING SYSTEM SOPRO 595 INTRA ORAL CAMERA SOPRO 617 INTRA OTAL CAMERA Mini Dock U USB2 SOPRO 717 INTRA ORAL CAMERA Mini Dock USB2 SOPRO 717 FIRST

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2009-10-29
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2009-04-06
FWF	Camera, Television, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2009-10-29
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2025-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2013-09-10
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2009-03-26
EHD	Unit, X-Ray, Extraoral With Timer	Dental	Class 2	872.1800	2009-03-26
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2009-03-26
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2016-06-17
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2015-08-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2010-07-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-12-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2014-09-12
NYH	Plaque Disclosing Kit	Dental	Class 2	872.1740	2013-03-13
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2013-03-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2011-04-04
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2011-04-04
NKC	Tubing/Tubing With Filter, Insufflation, Laparoscopic	Obstetrics/Gynecology	Class 1	884.1730	2009-11-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
NBL	Laser, Fluorescence Caries Detection	Dental	Class 2	872.1745	2023-12-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2007-12-13
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2007-12-13

Official Correspondent

Noelle Zuccarello

US Agent Details

Noelle Zuccarello Business: Acteon, Inc Email: noelle.zuccarello@acteongroup.com Phone: (800) 2896367

Related Public Records

Same Entity

SATELEC-ACTEON GROUP

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2243757	ACTEON, INC.	Mount Laurel, NJ, US
8044015	SATELEC-ACTEON GROUP	MERIGNAC Gironde, FR

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.
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.

Similar Registrations

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9610617	KARL STORZ SE & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615782. Last updated year: 2026. Please use registration number 9615782 when referencing this establishment in official correspondence.