# K982734: Olympus MH-246R Balloon Sheath, for Urinary Tract Use

- Pathway: 510(k) (Traditional)
- Applicant: The Olympus Optical Co.
- Decided: Oct 5, 1998 after 61 days
- Product code: ODG (Endoscopic Ultrasound System, 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: 2 generations back to K872027 (1987). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961048: Olympus MH-246R Balloon Sheath, Olympus America, Inc. (1996) Summary page 1.

## Most influential descendants
- K994069: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary Use (2000), 0 descendants of its own

## Indications for use
Olympus MH-246R Balloon Sheath have been designed to be used with the Olympus Ultrasonic Probe UM-2R/UM-3R, for intraluminal ultrasonic imaging of the urinary tract.

Source page: https://510kreport.com/device/K982734
Methodology: https://510kreport.com/methodology