510(k) · Cleared

Cleared

Retrieval Snare

K963750510(k) TraditionalCleared Nov 22, 199665-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 Nov 22, 1996 as substantially equivalent to K950496 (Boston Scientific Corp, 1995) and 2 other predicates after a 65-day review. Its family tree reaches back 1 generation to 1986.

Decided: Nov 22, 1996
Review: 65 days
Class: Class II
Product code: FGO
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K860269 (1986). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK860269 Van-Tec Deflecting Loop RetrieverVan-Tec, Inc. · 1986
This deviceK963750 Retrieval SnareBoston Scientific Corp · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K860269	Van-Tec Deflecting Loop Retriever	Van-Tec, Inc.	1986	—
0 (this device)	K963750	Retrieval Snare	Boston Scientific Corp	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0

FIG. 1 — Lineage of K963750, 1986–1996Source: 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? (3)

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
*	K950496	Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories Summary page 2 …FIC'S SNARE, PROFILE POLYPECTOMY SNARE, AND RETRIEVAL LOOP Microvasive BSC's Snare BSC'’s Profile B8SC’s Retrieval Retnieval Snare Polypectomy Loop Snare {This 510(k)) (K950496) (K941750) (K860269) USE ‘indication Retrieval of Resection, Removal and Removal of fareign foreign body such \| removal and cau…	Boston Scientific Corp	1995	—
*	K941750	Proposed Trademan Microvasive Polypectomy Snares Summary page 2 …E, PROFILE POLYPECTOMY SNARE, AND RETRIEVAL LOOP Microvasive BSC's Snare BSC'’s Profile B8SC’s Retrieval Retnieval Snare Polypectomy Loop Snare {This 510(k)) (K950496) (K941750) (K860269) USE ‘indication Retrieval of Resection, Removal and Removal of fareign foreign body such \| removal and cauterization…	Boston Scientific Corp	1994	3
*	K860269	Van-Tec Deflecting Loop Retriever Summary page 2 …POLYPECTOMY SNARE, AND RETRIEVAL LOOP Microvasive BSC's Snare BSC'’s Profile B8SC’s Retrieval Retnieval Snare Polypectomy Loop Snare {This 510(k)) (K950496) (K941750) (K860269) USE ‘indication Retrieval of Resection, Removal and Removal of fareign foreign body such \| removal and cauterization of bodies…	Van-Tec, Inc.	1986	—

Also cleared against K950496: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 3 ancestors has a recall of any class.
1 other device also cites its predicate K950496.

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 Retrieval Snare is indicated for use in grasping and retrieval of foreign body within the alimentary tract. These foreign bodies may include guidewires, pullwires, or plastic stents.

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/K963750 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963750: Retrieval Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963750

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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