Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2242464

FEI Number

2242464

Entity Name

COGENTIX MEDICAL, INC.

City/State/Country

ORANGEBURG, NY, US

Establishment Address

40 Ramland Rd S, ORANGEBURG, NY 10962, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

COGENTIX MEDICAL, INC. (Owner Number: 9105687)

Owner / Operator Contact Address

40 RAMLAND RD. SOUTH, --, Orangeburg, NY 10962, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UNITY Video Processors Stryker Video Ureteroscope Digital Cystoscope and EndoSheath CST-5000 Videocystoscope DVC-2010 DIGITAL VIDEO CAMERA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2018-12-10
OCS	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2018-12-10
EOX	Esophagoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4710	2018-12-10
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2018-12-10
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2018-12-10
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2012-11-19
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
FFS	Image, Illumination, Fiberoptic, For Endoscope	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2008-01-14
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	Class 1	878.4160	2007-08-10

Official Correspondent

Nicole Boser

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COGENTIX MEDICAL, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1223490	COGENTIX MEDICAL, INC.	Westborough, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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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 2242464. Last updated year: 2026. Please use registration number 2242464 when referencing this establishment in official correspondence.