# K253905: PrimeSight UltraView System

- Pathway: 510(k) (Traditional)
- Applicant: Cogentix Medical, Inc.
- Decided: Apr 7, 2026 after 123 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921244 (1992). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071127: Flexible Hysteroscope with Endosheath System, Vision-Sciences, Inc. (2007) Summary page 5.

## Indications for use
PrimeSight UltraView® Hybrid Flexible Video Cystoscope: Indications for Cystoscopy: - Endoscopic access of the lower urinary tract, including the bladder. - When combined with accessory instruments, the endoscopic system allows the user to perform various diagnostic and therapeutic procedures. Indications for Hysteroscopy: For accessing the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic surgical procedures. PrimeSight UltraView® All-in-One Video Processor Unit: The PrimeSight UltraView® All-in-One Video Processor Unit, when used in conjunction with a Laborie flexible videoscope (i.e., UV-6000 or UV-6000i) with Slide-On® EndoSheath® Technology, is indicated for the display and management of video and images during cystoscopy and hysteroscopy procedures.

Source page: https://510kreport.com/device/K253905
Methodology: https://510kreport.com/methodology