Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222140

FEI Number

1000121130

Entity Name

FREUDENBERG MEDICAL, LLC

City/State/Country

Jeffersonville, IN, US

Establishment Address

2301 Centennial Blvd, Jeffersonville, IN 47130, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Freudenberg Medical, LLC (Owner Number: 9000550)

Owner / Operator Contact Address

2301 Centennial Blvd., --, Jeffersonville, IN 47130, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190628

PMA Number

N/A

All Registered Proprietary Names

BNX Fine Needle Aspiration System Ultra Long RFA Focal Catheter 80 Beacon Fine Needle Fiducial System BNX Fine Needle Aspiration System Esophageal TTS, 120 Rapid Exchange (RXi) System and Navvus Catheter 90 RFA Focal Catheter 80 14 FR Low Profile Dilator System RFA Cleaning Cap SharkCore Fine Needle Biopsy System FlexSeal Introducer Sheath with Hydrophilic Coating

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-04-26
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2014-12-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-08-30
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2021-08-30
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2016-07-19
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2016-07-19
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2014-12-16
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2014-12-16
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	Class 2	876.4300	2021-08-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-08-30
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	Class 2	870.2870	2014-02-17
OBI	Catheter, Pressure Monitoring, Cardiac	Cardiovascular	Class 2	870.1200	2014-02-17
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-08-30
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2023-01-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-08-30
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2014-12-16
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2019-06-17

Official Correspondent

Acelio Hernandez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Freudenberg Medical, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012268721	Freudenberg Medical Plastic & Metal Manufacturing (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN
2031897	Freudenberg Medical, LLC	Baldwin Park, CA, US
2025182	Freudenberg Medical, LLC	CARPINTERIA, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0029-2012	Olympus America Inc.	2	OLYMPUS ViziShot EBUS Aspiration Needle Endobronchial Ultrasound (EBUS) Needle for Fine Needle Aspiration (FNA) - the needle has been designed to be used with ultrasonic endoscopes for ultrasonically guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222140. Last updated year: 2026. Please use registration number 1222140 when referencing this establishment in official correspondence.