COGENTIX MEDICAL, INC.

FDA Device Registration & Listing · Westborough, MA, US · Registration 1223490

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1223490
FEI Number
1000136543
Entity Name
COGENTIX MEDICAL, INC.
City/State/Country
Westborough, MA, US
Establishment Address
135 Flanders Rd, Westborough, MA 01581, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
COGENTIX MEDICAL, INC. (Owner Number: 9006902)
Owner / Operator Contact Address
135 Flanders Road, --, Westborough, MA 01581, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K072180
PMA Number
N/A

All Registered Proprietary Names

Catheter for Use with Urodynamics System ENT EndoSheath Technology CST-5000 Videocystoscope EndoSheath Technology

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FEN Device, Cystometric, Hydraulic Gastroenterology, Urology Class 2 876.1620 2018-12-10
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2014-11-10
FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2009-03-12
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2009-03-12
FFS Image, Illumination, Fiberoptic, For Endoscope Gastroenterology, Urology Class 2 876.1500 2009-03-12

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
2242464 COGENTIX MEDICAL, INC. ORANGEBURG, NY, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935716 KARL STORZ Endoscopy-America, Inc. KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE 1995-11-16
K230752 FUJIFILM Healthcare Americas Corporation Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) 2023-09-15

Similar Registrations

Registration Number Establishment Name Location
3004967767 DELTA MED SPA Delebio Sondrio, IT
3010400865 WELL LEAD MEDICAL CO. LTD GUANGZHOU Guangdong, CN
3006174295 STERLAB SIGNES Var, FR
3043503763 MEDICA MEDITERRANEE Menzel Jemil Bizerte, TN
9615942 Medica S.p.A. Medolla Modena, IT
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1223490. Last updated year: 2026. Please use registration number 1223490 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.