# K091495: Single Use 3-Lumen Extraction Balloon V, Model V B-V233P-a,B-V233P-B,B-V433P-a,B-V433P-B, BV243Q-a, B-V243Q-B, B-V443Q-a

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Sep 3, 2009 after 106 days
- Product code: LQR (Dislodger, Stone, Biliary)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904669 (1991). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033333: Single Use 3-Lumen Balloon Catheter, Models B-230Q-a and B-230Q-B, Aomori Olympus Co., Ltd. (2003) Summary page 2.

## Recalls of this device
- Jan 4, 2021 · Class II · Z-0968-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0966-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.
- Jan 4, 2021 · Class II · Z-0967-2021: Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

## Indications for use
These instruments have been designed to be used with Olympus endoscopes to. endoscopically remove stones such as calculi, pancreatic and common bile duct stones, to remove bile sludge from the biliary system and to facilitate injection of contrast medium into the biliary system.

Source page: https://510kreport.com/device/K091495
Methodology: https://510kreport.com/methodology