# K041606: Extractor RX Retrieval Balloon

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jul 7, 2004 after 22 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Extractor RX Retrieval Balloon: named in the summary without a submission number
- (no number) Boston Scientific Extractor RX Retrieval Catheter: named in the summary without a submission number

## Most influential descendants
- K102082: Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons, Extractor Pro DL Retrieval Ballons Model M005470 (2010), 3 descendants of its own
- K211021: Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible (2022), 1 descendant of its own
- K253132: Single use stone retrieval balloons (2026), 0 descendants of its own
- K131642: RSH Biliary Stone Removal Device (2013), 0 descendants of its own

## Indications for use
Indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon

Source page: https://510kreport.com/device/K041606
Methodology: https://510kreport.com/methodology