Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011879048

FEI Number

3011879048

Entity Name

Venclose, Inc.

City/State/Country

San Jose, CA, US

Establishment Address

2570 N 1st St Fl 2 # 221, San Jose, CA 95131, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

C.R. Bard (Owner Number: 10049916)

Owner / Operator Contact Address

850 W Rio Salado Parkway, Tempe, AZ 85281, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211806

PMA Number

N/A

All Registered Proprietary Names

Venclose digiRF Generator Venclose digiRF Generator Venclose EVSRF Catheter Venclose Power Cord Venclose System Venclose Foot Pedal Venclose EVSRF Catheter; Venclose RF Ablation Catheter Venclose digiRF Generator VENCLOSE MAVEN Perforator RF Ablation Catheter Venclose Maven Catheter Venclose Maven System (digiRF Generator and Maven Catheter) Venclose Foot Pedal Venclose Power Cord

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-09-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-09-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-10-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-08-12

Official Correspondent

Kristen Ortiz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

C.R. Bard

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
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

Similar Registrations

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3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011879048. Last updated year: 2026. Please use registration number 3011879048 when referencing this establishment in official correspondence.