510(k) Report

510(k) · Cleared

Cleared

Stone Dislodger, Basket

K951309510(k) TraditionalCleared May 17, 199556-day reviewClass II21 CFR 876.4680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · FGO Dislodger, Stone, Flexible

Cleared on May 17, 1995 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
May 17, 1995
Review
56 days
Class
Class II
Product code
FGO
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2002: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951309 Stone Dislodger, BasketBoston Scientific Corp · 1995
  2. Descendant · cites it directly · 3 of its ownK970121 Stone Dislodger, BasketBoston Scientific Corp · 1997
  3. Descendant · 2 generations on · 0 of its ownK113692 XENXXenolith Medical · 2012
  4. Descendant · 2 generations on · 0 of its ownK090430 Backstop and Backstop InjectorPluromed, Inc. · 2009
  5. Descendant · cites it directly · 0 of its ownK012581 Reprocessed Stone Retrieval BasketsSterilmed, Inc. · 2002 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K970121Stone Dislodger, BasketBoston Scientific Corp · 1997 · cites it directly3descendants
  • K113692XENXXenolith Medical · 2012 · 2 generations on0descendants
  • K090430Backstop and Backstop InjectorPluromed, Inc. · 2009 · 2 generations on0descendants
  • K012581Reprocessed Stone Retrieval BasketsSterilmed, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951309Stone Dislodger, BasketBoston Scientific Corp1995—
+1K970121Stone Dislodger, BasketBoston Scientific Corp1997—
+2K113692XENXXenolith Medical2012—
+2K090430Backstop and Backstop InjectorPluromed, Inc.2009—
+1K012581Reprocessed Stone Retrieval BasketsSterilmed, Inc.20021

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200210
200910
201210
FIG. 1 — Lineage of K951309, 1995–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FGO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970121Stone Dislodger, BasketBoston Scientific Corp19973
K012581Reprocessed Stone Retrieval BasketsSterilmed, Inc.20020

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K970121 (Boston Scientific Corp, 1997) has gone furthest, with 3 descendants of its own.

How does its category compare?

All FGO devices

FGO Dislodger, Stone, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGO

FDA has decided no FGO device since 2007.

Median 510(k) review, days · FGO

Too few FGO 510(k)s in any year since 2007 to give a median.

Recalls per year · FGO

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGO

10in 2025

2007: 22008: 232009: 322010: 112011: 152012: 132013: 152014: 42015: 152016: 212017: 172018: 142019: 252020: 192021: 142022: 182023: 142024: 192025: 10
2007high 32 (2009) · low 2 (2007)2025

MAUDE reports naming product code FGO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—023
20090—032
20100—011
20110—115
20120—013
20130—015
20140—04
20150—015
20160—021
20170—017
20180—014
20190—025
20200—019
20210—014
20220—018
20230—014
20240—019
20250—010
20260—0—

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4,014 FDA decisions under this applicant name. See the company

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Recent decisions in FGO

The FGO category page

  • K001563Scipro (TM) Flexible Stone Dislodger and Retrieval SetScion Cardiovascular, Inc. · 20002 recalls
  • K970121Stone Dislodger, BasketBoston Scientific Corp · 1997
  • K963750Retrieval SnareBoston Scientific Corp · 1996
  • K962676Disposable Endoscopic Retrieval DeviceUnited States Endoscopy Group, Inc. · 19962 recalls
  • K933261Grasping ForcepsSurgitek · 1994

https://510kreport.com/device/K951309 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951309: Stone Dislodger, Basket.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951309

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026