Data / Medical devices / United States / Cogentix Medical, Inc.
Cogentix Medical, Inc.: FDA-registered device maker in Orangeburg, NY, United States, 4 510(k) clearances
Cogentix Medical, Inc. is registered with the FDA (registration 2242464) in Orangeburg, NY, United States. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 7, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2242464
- Address
- 40 Ramland Rd S, Orangeburg, NY, United States, 10962
- Owner or operator
- COGENTIX MEDICAL, INC. (9105687)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 3, 2007
- Registered through
- 2026
- Brand names listed
- BLS-1000 Battery Powered Light Source, CST-4000/4000i Cystoscope/Hysteroscope, CST-5000 Videocystoscope, Digital Cystoscope and EndoSheath, Fiber Cystoscope, EndoSheath & Battery Light Source, PrimeSight UltraView System, UNITY Video Processors
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Specification developer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | OCS | 2 | Specification developer | accessdata.fda.gov |
| Esophagoscope (Flexible Or Rigid) | EOX | 2 | Specification developer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | 2 | Manufacturer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Manufacturer | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 7, 2026 | K253905 | PrimeSight UltraView System | FAJ | Substantially Equivalent | Cogentix Medical, Inc. | accessdata.fda.gov |
| November 15, 2018 | K181292 | PrimeSight UNITY 9000 Video Processor, PrimeSight UNITY 9100 Video Processor | EOX | Substantially Equivalent | Cogentix Medical, Inc. | accessdata.fda.gov |
| December 18, 2007 | K072180 | VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM | FAJ | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| November 16, 2007 | K071127 | FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM | HIH | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 27, 2011 | 60806 | Not yet classified | Terminated | Product is a lithium ion battery charger sold as both a stand-alone accessory, and as part of endoscopy system sets. --- Stand alone labeling: Vision Sciences Battery Charger, Lithium Ion [REF] 07-3051; [MFG Symbol] Visi | Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged. | accessdata.fda.gov |
Compare with other makers
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
- All makers of Image, Illumination, Fiberoptic, For Endoscope
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Led Light Source
- All makers of Nasopharyngoscope (Flexible Or Rigid)
Updated April 7, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.