# K970052: Extractorrx

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 25, 1997 after 77 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 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) Microvasive Extractor XL: named in the summary without a submission number

## Most influential descendants
- K010610: Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527 (2001), 6 descendants of its own
- K040137: Wilson-Cook Usw Cap and Wire Lock (2004), 4 descendants of its own
- K213483: SnapLoc Wire Lock (2022), 0 descendants of its own
- K220247: Guidewire Locking Device (2022), 0 descendants of its own
- K210353: AutoCap RX (2021), 0 descendants of its own

## Recalls of this device
- Jan 29, 2003 · Not classified · Z-0551-03: Breach in sterile barrrier may compromise sterility
- Jan 29, 2003 · Not classified · Z-0552-03: Breach in sterile barrrier may compromise sterility
- Jan 29, 2003 · Not classified · Z-0553-03: Breach in sterile barrrier may compromise sterility

## Indications for use
The ExtractorRX is 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/K970052
Methodology: https://510kreport.com/methodology