# K951972: Cabot Medical Ultra Flow Cystourethroscope System with Operating & Diagnostic Sheaths

- Pathway: 510(k) (Traditional)
- Applicant: Cabot Medical Corp.
- Decided: Jul 21, 1995 after 85 days
- Product code: FBO (Cystourethroscope)
- 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K021166: Acmi Bipolar Rectoscope, Model Eiwe-BR (2002), 4 descendants of its own
- K031001: Acmi Vista CTR Bipolar Loop Electrode (2003), 3 descendants of its own
- K062720: S-Line Bipolar Resectoscopes and Bipolar Electrodes (2007), 2 descendants of its own
- K191341: Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags (2019), 1 descendant of its own
- K050910: Roei Working Element and Roel Cutting Loops (2005), 1 descendant of its own

Source page: https://510kreport.com/device/K951972
Methodology: https://510kreport.com/methodology