Data / Medical devices / United States / Cogentix Medical, Inc.
Cogentix Medical, Inc.: FDA-registered device maker in Westborough, MA, United States, 2 510(k) clearances
Cogentix Medical, Inc. is registered with the FDA (registration 1223490) in Westborough, MA, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 18, 2007. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1223490
- FEI number
- 1000136543
- Address
- 135 Flanders Rd, Westborough, MA, United States, 01581
- Owner or operator
- COGENTIX MEDICAL, INC. (9006902)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 12, 2009
- Registered through
- 2026
- Brand names listed
- CST-5000 Videocystoscope, Catheter for Use with Urodynamics System, ENT EndoSheath Technology, EndoSheath Technology
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Manufacturer | accessdata.fda.gov |
| Device, Cystometric, Hydraulic | FEN | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | 2 | Manufacturer | accessdata.fda.gov |
| Hysteroscope (And Accessories) | HIH | 2 | Manufacturer | accessdata.fda.gov |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| 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 |
Compare with other makers
- All makers of Hysteroscope (And Accessories)
- All makers of Endoscopic Access Overtube, Gastroenterology-Urology
- All makers of Cystoscope And Accessories, Flexible/Rigid
- All makers of Image, Illumination, Fiberoptic, For Endoscope
- All makers of Device, Cystometric, Hydraulic
Updated December 18, 2007. 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.