Cogentix Medical, Inc. · Class II · Cleared Apr 7, 2026
| K-number | K253905 |
| Device name | PrimeSight UltraView System |
| Applicant | Cogentix Medical, Inc. |
| Product code | FAJ |
| Device class | Class II |
| Decision date | Apr 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The PrimeSight UltraView System is an endoscopy platform consisting of a hybrid flexible video cystoscope (UV-6000/6000i) and an all-in-one video processor unit (UVP-1000) used for diagnostic and therapeutic procedures in the lower urinary tract, bladder, cervical canal, and uterine cavity. It displays and manages video and images during cystoscopy and hysteroscopy procedures, with compatible Slide-On EndoSheath Technology for patient protection.
The subject device transitions from a fiberoptic system (predicate K071127) to a video endoscopic system using electronic image transmission with a CMOS image sensor, all-in-one computer, and camera control unit. It incorporates updated software (UNITY 3.0 based on UNITY 2.0) and IPS display technology. Overall usability and handling remain unchanged from reference devices K072180 and K181292.
IEC 62304 (software life cycle), IEC 60601-1/1-2/1-6/2-18 (electrical safety and EMC), IEC 62471 (photobiological safety), ISO 9022-2 (environmental testing), ISO 8600-1/3/5 (optical equivalency), ISO 12233 (digital camera resolution), ISO 62366-1 (usability), ISO 10993-1 (biocompatibility), ISO 17664-1 and ISO 11135 (reprocessing/sterilization).
The device maintains the same intended use and indications as primary predicate K071127 (CST-2000A hysteroscope with EndoSheath). Performance testing and bench testing demonstrate equivalence to reference devices K072180 and K181292. The transition from fiberoptic to electronic image transmission does not raise new safety or effectiveness concerns, and all design outputs meet design inputs with predefined acceptance criteria met.
View the full FDA submission: accessdata.fda.gov