# K946358: Endoscopic Biliary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Apr 11, 1995 after 102 days
- Product code: LQR (Dislodger, Stone, Biliary)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K191789: Stonetome Stone Removal Device (2019), 0 descendants of its own

## Recalls of this device
- Jan 8, 2009 · Not classified · Z-1011-2009: The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when 
- Jan 8, 2009 · Not classified · Z-1012-2009: The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when 
- Jan 8, 2009 · Not classified · Z-1010-2009: The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when 
- May 19, 2006 · Not classified · Z-1112-06: Lack of assurance of sterility, as the sterile barrier may fail.
- May 19, 2006 · Not classified · Z-1113-06: Lack of assurance of sterility, as the sterile barrier may fail.
- May 19, 2006 · Not classified · Z-1114-06: Lack of assurance of sterility, as the sterile barrier may fail.
- May 19, 2006 · Not classified · Z-1110-06: Lack of assurance of sterility, as the sterile barrier may fail.
- May 19, 2006 · Not classified · Z-1111-06: Lack of assurance of sterility, as the sterile barrier may fail.
- May 19, 2006 · Not classified · Z-1109-06: Lack of assurance of sterility, as the sterile barrier may fail.

Source page: https://510kreport.com/device/K946358
Methodology: https://510kreport.com/methodology