510(k) · Cleared

Cleared

Stone Dislodger, Basket

K970121510(k) TraditionalCleared Apr 2, 199778-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 Apr 2, 1997 as substantially equivalent to K871777 (Van-Tec, Inc., 1987) and 3 other predicates after a 78-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it.

Decided: Apr 2, 1997
Review: 78 days
Class: Class II
Product code: FGO
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K871777 (1987). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK871777 Van-Tec Reusable Helical Stone BasketVan-Tec, Inc. · 1987
This deviceK970121 Stone Dislodger, BasketBoston Scientific Corp · 1997
Descendant · cites it directly · 0 of its ownK113692 XENXXenolith Medical · 2012
Descendant · cites it directly · 0 of its ownK090430 Backstop and Backstop InjectorPluromed, Inc. · 2009
Descendant · cites it directly · 0 of its ownK012581 Reprocessed Stone Retrieval BasketsSterilmed, Inc. · 2002 · Recalled

Most influential descendants

Showing 3 of 3 · See all

K113692XENXXenolith Medical · 2012 · cites it directly0descendants
K090430Backstop and Backstop InjectorPluromed, Inc. · 2009 · cites it directly0descendants
K012581Reprocessed Stone Retrieval BasketsSterilmed, Inc. · 2002 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871777	Van-Tec Reusable Helical Stone Basket	Van-Tec, Inc.	1987	—
0 (this device)	K970121	Stone Dislodger, Basket	Boston Scientific Corp	1997	—
+1	K113692	XENX	Xenolith Medical	2012	—
+1	K090430	Backstop and Backstop Injector	Pluromed, Inc.	2009	—
+1	K012581	Reprocessed Stone Retrieval Baskets	Sterilmed, Inc.	2002	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1992	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2009	1	0
2012	1	0

FIG. 1 — Lineage of K970121, 1987–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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? (4)

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	Applicant	Decided	Recalls
*	K871777	Van-Tec Reusable Helical Stone Basket Summary page 1 …tripsy, to endoscopically grasp, manipulate and remove calculi and other foreign objects. The proposed devices are “Substantially Equivalent” to the predicate devices (K871777, K871779, K925495, K951309) indicated for use during urological and/or gastroenterological procedures to endoscopically grasp, ma…	Van-Tec, Inc.	1987	—
*	K871779	Helical Stone Basket (Disposable) Summary page 1 …o endoscopically grasp, manipulate and remove calculi and other foreign objects. The proposed devices are “Substantially Equivalent” to the predicate devices (K871777, K871779, K925495, K951309) indicated for use during urological and/or gastroenterological procedures to endoscopically grasp, manipulate…	Van-Tec, Inc.	1987	—
*	K925495	Microvasive Insurg Helical & Mini-Helical Baskets Summary page 1 …pically grasp, manipulate and remove calculi and other foreign objects. The proposed devices are “Substantially Equivalent” to the predicate devices (K871777, K871779, K925495, K951309) indicated for use during urological and/or gastroenterological procedures to endoscopically grasp, manipulate and remo…	Boston Scientific Corp	1992	—
*	K951309	Stone Dislodger, Basket Summary page 1 …rasp, manipulate and remove calculi and other foreign objects. The proposed devices are “Substantially Equivalent” to the predicate devices (K871777, K871779, K925495, K951309) indicated for use during urological and/or gastroenterological procedures to endoscopically grasp, manipulate and remove calcul…	Boston Scientific Corp	1995	—

What descends from it? (3)

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

Number	Device	Applicant	Decided
K113692	XENX	Xenolith Medical	2012
K090430	Backstop and Backstop Injector	Pluromed, Inc.	2009
K012581	Reprocessed Stone Retrieval Baskets	Sterilmed, Inc.	2002

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?

None of the 4 ancestors has a recall.
Of its descendants, K113692 (Xenolith Medical, 2012) has gone furthest, with 0 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

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

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

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	2
2008	—	0	23
2009	—	0	32
2010	—	0	11
2011	—	1	15
2012	—	0	13
2013	—	0	15
2014	—	0	4
2015	—	0	15
2016	—	0	21
2017	—	0	17
2018	—	0	14
2019	—	0	25
2020	—	0	19
2021	—	0	14
2022	—	0	18
2023	—	0	14
2024	—	0	19
2025	—	0	10
2026	—	0	—

What is it indicated for?

The proposed Stone Dislodger is intended to be used during urological and/or gastroenterological procedures including use during intracorporeal lithotripsy, to endoscopically grasp, manipulate and remove calculi and other foreign objects.

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/K970121 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970121: 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/K970121

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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