510(k) · Cleared
Recalled · 2003Extractorrx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Mar 25, 1997 after a 77-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 25, 1997
- Review
- 77 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 3
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK970052 ExtractorrxBoston Scientific Corp · 1997
- Descendant · cites it directly · 6 of its ownK010610 Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Boston Scientific Corp · 2001
- Descendant · 2 generations on · 4 of its ownK040137 Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK213483 SnapLoc Wire LockWilson Cook Medical · 2022
- Descendant · 3 generations on · 0 of its ownK220247 Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK210353 AutoCap RXBoston Scientific Corporation · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K010610Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527Boston Scientific Corp · 2001 · cites it directly6descendants
- K040137Wilson-Cook Usw Cap and Wire LockWilson-Cook Medical, Inc. · 2004 · 2 generations on4descendants
- K213483SnapLoc Wire LockWilson Cook Medical · 2022 · 3 generations on0descendants
- K220247Guidewire Locking DeviceMicro-Tech (Nanjing) Co., Ltd. · 2022 · 3 generations on0descendants
- K210353AutoCap RXBoston Scientific Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970052 | Extractorrx | Boston Scientific Corp | 1997 | — |
| +1 | K010610 | Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527 | Boston Scientific Corp | 2001 | — |
| +2 | K040137 | Wilson-Cook Usw Cap and Wire Lock | Wilson-Cook Medical, Inc. | 2004 | — |
| +3 | K213483 | SnapLoc Wire Lock | Wilson Cook Medical | 2022 | — |
| +3 | K220247 | Guidewire Locking Device | Micro-Tech (Nanjing) Co., Ltd. | 2022 | — |
| +2 | K210353 | AutoCap RX | Boston Scientific Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FGE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Microvasive Extractor XL Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K010610 | Rapid Exchange Biopsy Cap and Locking Device #4526 & 4527 | 2001 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 29, 2003 | Not classified | Z-0551-03 | Other | Breach in sterile barrrier may compromise sterility |
| Jan 29, 2003 | Not classified | Z-0552-03 | Other | Breach in sterile barrrier may compromise sterility |
| Jan 29, 2003 | Not classified | Z-0553-03 | Other | Breach in sterile barrrier may compromise sterility |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K010610 (Boston Scientific Corp, 2001) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970052: Extractorrx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970052
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026