# K200369: OES Elite Ureteroscopes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Aug 28, 2020 after 196 days
- Product code: FGB (Ureteroscope 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: 2 generations back to K011849 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052044: Acmi Autoclavable Ureteroscope, Models MR-6A and MR-6AL, Acmi Corporation (2005) Summary page 4.
- K011849: Micro-6-Series (MR-6, MR-6L) Ureteroscopes, Mro-6 Series (MR-633, MR-642) Ureteroscopes, Mro-7 Series (Mro-733) Ureteros, Circon Video (2001) Summary page 4.

## Indications for use
The Olympus ureteroscopes can be utilized for endoscopic observation and therapy in the ureters, urethra, and urinary bladder. Semi-rigid optical instrument for the visualization of the following diagnostic and therapeutic procedures: - Transurethral inspection of the ureters and renal pelvis for diagnosis - Transurethral insertion of catheters, guide wires, cannulas, forceps, electrodes, baskets, lithotripsy probes and laser fibres into the ureter - Transurethral treatment and removal of tissue, catheters, guide wires, debris and stones from urethra, urinary bladder and ureters - Transurethral treatment and removal of tissue and stones from the ureters and renal pelvis. The products are not intended for treatment of infants. For children (>2 years) and adults, refer to the particular constitution and anatomy of the patient.

Source page: https://510kreport.com/device/K200369
Methodology: https://510kreport.com/methodology