# K091600: Directvision Guide System

- Pathway: 510(k) (Traditional)
- Applicant: Percuvision, LLC
- Decided: Aug 25, 2009 after 83 days
- Product code: FGC (Urethroscope)
- 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: 2 generations back to K932987 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020310: Davlite Microendoscope & Accessories, Davlite Technologies (2002)

## Indications for use
The DirectVision TM Guide System is indicated for use in the visual examination of the urethra and bladder when placing the PercuCath Urologic Catheter.

Source page: https://510kreport.com/device/K091600
Methodology: https://510kreport.com/methodology