Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680001

FEI Number

3002808445

Entity Name

Venusa de Mexico S. de R.L de C.V

City/State/Country

CIUDAD JUAREZ Chihuahua, MX

Establishment Address

CALLE HERTZ 1525, Parque Industrial Antonio J. Bermudez, CIUDAD JUAREZ Chihuahua 32470, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Lake Region Medical (Owner Number: 9048369)

Owner / Operator Contact Address

340 Lake Hazeltine Drive, Chaska, MN 55318, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Wire, Guide, Catheter NaviPro ORATEC SPINECATH I Covidien electrosurgical HYSTEROSCOPE (AND ACCESSORIES) - Medtronic Depuy Mitek SMITH & NEPHEW INC., ENDOSCOPY DIVISION STONE CONE(TM) NITINOL U BOSTON SCIENTIFIC SMITH AND NEPHEW ENDOSCOPY St. Jude Medical NEUROTHERM NEUROTHERM KCI USA, INC. (KINETIC CONCEPTS, INC.) Covidien electrosurgical Covidien electrosurgical Biotronick, Inc. SMITH & NEPHEW INC., ENDOSCOPY DIVISION Covidien electrosurgical OnePort Surgical Trocar System BLES HANDLE EN BLOC Biopsy System NEO HANDLE FUTURE MEDICAL SYSTEMS, INC SMITH NEPHEW CDS SYSTEM SMITH & NEPHEW INC., ENDOSCOPY DIVISION Intact Medical Corporation Biotronick, Inc. V.A.C. Veraflo Cleanse Choice Dressing Kit, Large V.A.C. Veraflo Cleanse Choice Dressing Kit, Medium Stryker DePuy Mitek Stryker SMITH & NEPHEW INC., ENDOSCOPY DIVISION Dendreon Corporation NEPHEW RF DENERVATION PROBES SMITH Wire, Guide, Catheter ZIPwire Biosense Webster Inc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OCY	Endoscopic Guidewire, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-12-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2005-05-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-21
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2021-11-23
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-10-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-02-21
FGO	Dislodger, Stone, Flexible	Gastroenterology, Urology	Class 2	876.4680	2005-10-25
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2013-01-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-02-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-02-21
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2014-10-29
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-06-03
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-06-03
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2011-01-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-21
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-03-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-02-21
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-02-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-02-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2008-01-08
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2008-08-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2008-08-01
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2011-04-05
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2006-09-28
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-02-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-02-21
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2016-02-16
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-03-23
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2026-05-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2015-10-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-01-05
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2012-02-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-02-21
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2007-12-27
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2006-10-26
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2006-10-26
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-12-17
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2013-03-19
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2013-03-19
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2013-03-19
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2013-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

Charlene Grilletto Business: Lake Region Medical Email: charlene.grilletto@integer.net Phone: (215) 5342280

Related Public Records

Same Entity

Lake Region Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004063494	Lake Region Medical	TRENTON, GA, US
9681477	LAKE REGION MEDICAL LIMITED	NEW ROSS Wexford, IE
2126666	Lake Region Medical	CHASKA, MN, US
3006010712	BRIVANT, LTD.	GALWAY, IE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0006-2013	US Endoscopy Group Inc	2	Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Z-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704

Similar Registrations

Registration Number	Establishment Name	Location
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
1828132	BOSTON SCIENTIFIC CORPORATION	SPENCER, IN, US
3012536737	Merit Medical Canada Ltd.	Markham Ontario, CA
2126666	Lake Region Medical	CHASKA, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680001. Last updated year: 2026. Please use registration number 9680001 when referencing this establishment in official correspondence.