# K091962: Polyscope Flexible Endoscopy Catheter; 10,000 Pixel Fiber Optic; Xenon Light Source, Model LS-200

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Sep 30, 2009 after 91 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
Longest line of descent: 4 generations back to K853585 (1986). 10 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050403: Spyglass Direct Visulation Probe, Boston Scientific Corp (2005) Summary page 1.
- K072957: Evis Exera II 180 System, Olympus Medical Systems Corporation (2008) Summary page 1.
- K051645: Evis Exera 160A System, Olympus Medical Systems Corporation (2005) Summary page 2.

## Most influential descendants
- 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
- K141358: Cellvizio 100 Series with System Confocal Miniprobes (2014), 9 descendants of its own
- K160416: CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes (2016), 7 descendants of its own
- K150831: Cellvizio 100 Series System with Confocal Miniprobes (2015), 7 descendants of its own
- K172844: Cellvizio 100 Series System with Confocal Miniprobes (2017), 6 descendants of its own

## Indications for use
The PolyScope Flexible Endoscope is indicated in flexible endoscopic procedures for diagnostic and therapeutic applications where flexible endoscopes are standard of care including: · Gastroenterology, including procedure of the Biliary system involving the hepatic and pancreatic ducts. · Urology, including procedures involving the bladder, ureter, renal pelvis and kidney. The PolyScope Xenon-Endoscopic light source LS 200 provides white examination light (sunlight spectrum) for all endoscopic applications including: During video endoscopy. During fiber endoscopy. During micro-endoscopy. During endoscopy using rigid optics. During usage of forehead illumination.

Source page: https://510kreport.com/device/K091962
Methodology: https://510kreport.com/methodology