# K961048: Olympus MH-246R Balloon Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Sep 16, 1996 after 185 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: 1 generation back to K872027 (1987). 3 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K872027: Olympus GF-UM2/EU-M2, Olympus Corp. (1987) Summary page 1.
- K882061: Olympus GF-UM3/EU-M3, Olympus Corp. (1988) Summary page 1.
- K926514: Endoscopic Ultrasound System Type 20, Olympus Corp. (1993) Summary page 1.

## Most influential descendants
- K982733: Olympus MH-246R Balloon Sheath, for Bronchial Use (1998), 1 descendant of its own
- K982734: Olympus MH-246R Balloon Sheath, for Urinary Tract Use (1998), 1 descendant of its own
- K994106: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial Use (2000), 0 descendants of its own
- K994069: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary Use (2000), 0 descendants of its own
- K982725: Olympus MH-246R Balloon Sheath, for Female Reproductive Tract Use (1998), 0 descendants of its own

## Indications for use
The balloon sheath MH-246R is designed to be used with the Olympus Ultrasonic Probe UM-2R/3R for intraluminal ultrasonic imaging of the gastrointestinal tract wall and surrounding organs.

Source page: https://510kreport.com/device/K961048
Methodology: https://510kreport.com/methodology