# K963354: 5 Star Medical Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Five Star Medical, Inc.
- Decided: Sep 8, 1997 after 378 days
- Product code: ODF (Mini Endoscope, Gastroenterology-Urology)
- 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.
27 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K050403: Spyglass Direct Visulation Probe (2005), 26 descendants of its own
- K052194: Spyglass Direct Visualization Probe and Ocular (2005), 20 descendants of its own
- K091962: Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model LS-200 (2009), 11 descendants of its own
- K132389: Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and Cystolflex F (Both Trade Marked (2014), 10 descendants of its own
- K090170: Spyscope Access and Delivery Catheter (2009), 10 descendants of its own

Source page: https://510kreport.com/device/K963354
Methodology: https://510kreport.com/methodology