# K012758: Ureteroscope, Pediatric Cystoureteroscope, Operating Pediatric Cystoureteroscope, Models MR-9, MR-9L,

- Pathway: 510(k) (Traditional)
- Applicant: Circon Video
- Decided: Apr 9, 2002 after 235 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACMI Circon preamendment ureteroscope (circa, 1971): named in the summary without a submission number

## Indications for use
The intended use for these Semi-Rigid ureteroscopes is for examination/operation of the urinary tract and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Source page: https://510kreport.com/device/K012758
Methodology: https://510kreport.com/methodology