# K193039: Single Use Balloon Dilator V (with knife)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Dec 17, 2019 after 47 days
- Product code: KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories))
- Device class: 2
- Regulation: 21 CFR 876.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K910722 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150142: Single Use Balloon Dilator V (with Knife), Olympus Medical Systems Corp. (2015) Summary page 5.

## Indications for use
These instruments have been designed to be used with an Olympus endoscope for papillotomy and for dilating the major papilla to retrieve biliary stones.

Source page: https://510kreport.com/device/K193039
Methodology: https://510kreport.com/methodology