# K102082: Extractor Pro RX Retrieval Ballons, Extractor Pro XL Retrieval Ballons, Extractor Pro DL Retrieval Ballons Model M005470

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Aug 23, 2010 after 28 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931619 (1993). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041606: Extractor RX Retrieval Balloon, Boston Scientific Corp (2004) Summary page 1.
- K931619: Microvasive Extractor, Retrieval Balloon Catheter, Boston Scientific Corp (1993) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Aug 28, 2025 · Class II · Z-2618-2025: The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
- Apr 27, 2015 · Class II · Z-1941-2015: One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
- Dec 18, 2013 · Class II · Z-0710-2014: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
- Dec 18, 2013 · Class II · Z-0711-2014: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
- Dec 18, 2013 · Class II · Z-0712-2014: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size

## Indications for use
The Extractor Pro Retrieval Balloon Catheters are 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/K102082
Methodology: https://510kreport.com/methodology