510(k) · Cleared

Cleared

Rotosnare

K992477510(k) TraditionalCleared Aug 24, 199929-day reviewClass II21 CFR 876.4300

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

Cleared on Aug 24, 1999 as substantially equivalent to K950496 (Boston Scientific Corp, 1995) after a 29-day review. Its family tree reaches back 1 generation to 1995. 17 later devices descend from it.

Decided: Aug 24, 1999
Review: 29 days
Class: Class II
Product code: FDI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950496 (1995). 17 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK950496 Snare, Flexible, Electrosurgical Cutting & Coagulation Device &…Boston Scientific Corp · 1995
This deviceK992477 RotosnareInscope, LLC · 1999
Descendant · cites it directly · 15 of its ownK131700 Sensation Short Throw, Captiflex, Captivator, Captivator II…Boston Scientific Corp · 2013 · Recalled
Descendant · 2 generations on · 10 of its ownK133987 Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · Recalled
Descendant · 3 generations on · 5 of its ownK172729 Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2018
Descendant · 2 generations on · 4 of its ownK160637 Rotatable SnaresBoston Scientific Corporation · 2016
Descendant · 3 generations on · 3 of its ownK172758 Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2008high 4 (2022) · low 0 (2009)2026

Most influential descendants

Showing 5 of 17 · See all

K131700Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use…Boston Scientific Corp · 2013 · cites it directly15descendants
K133987Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · 2 generations on10descendants
K172729Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2018 · 3 generations on5descendants
K160637Rotatable SnaresBoston Scientific Corporation · 2016 · 2 generations on4descendants
K172758Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018 · 3 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950496	Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories	Boston Scientific Corp	1995	—
0 (this device)	K992477	Rotosnare	Inscope, LLC	1999	—
+1	K131700	Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile…	Boston Scientific Corp	2013	8
+2	K133987	Captivator II,Single-Use Polypectomy Snares	Boston Scientific Corporation	2014	1
+3	K172729	Polypectomy Snare	Hangzhou AGS MedTech Co., Ltd.	2018	—
+2	K160637	Rotatable Snares	Boston Scientific Corporation	2016	—
+3	K172758	Rotatable Snares, Non-Rotatable Snares	Zhejiang Chuangxiang Medical Technology Co., Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2013	1	0
2014	1	0
2016	1	0
2017	1	0
2018	3	0
2019	2	0
2020	2	0
2022	4	0
2023	1	0

FIG. 1 — Lineage of K992477, 1995–2023Source: 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 FDI? 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 FDI device

#1 K251692 Advanced Tissue Resection Devicescore 10.9 · 1 generation · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K950496	Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories Summary page 1 …ntially equivalent to the Microvasive Single- Use Polypectomy Snare, which are legally marketed and distributed by the Boston Scien- tific Corporation pursuant to 510(k) K950496. Device Description The InScope, LLC rotatable snare consists of an actuation handle, rotation handle and snare loop. The loop…	Boston Scientific Corp	1995	—

Also cleared against K950496: 1 other device →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K131700	Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use…	Boston Scientific Corp	2013	15
K073288	Ethicon Endo Surgery Articulating Snare	Ethicon Endo-Surgery, Inc.	2008	0

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?

Its one ancestor has no recall.
Of its descendants, K131700 (Boston Scientific Corp, 2013) has gone furthest, with 15 descendants of its own.
1 other device also cites its predicate K950496.

How does its category compare?

All FDI devices

FDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDI

1in 2023

2007high 5 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDI

247in 2022

2007high 247 (2022) · low 47 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FDI

2in 2025

2007high 2 (2025) · low 0 (2007)2026

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

Adverse event reports per year · FDI

274in 2025

2007high 487 (2020) · low 48 (2007)2025

MAUDE reports naming product code FDI, 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	0	—	0	48
2008	2	—	0	201
2009	1	—	0	265
2010	0	—	1	174
2011	1	—	0	177
2012	1	—	0	162
2013	3	87	0	191
2014	5	47	0	345
2015	3	62	1	195
2016	1	—	0	223
2017	1	—	0	154
2018	4	214	0	181
2019	3	100	0	135
2020	2	—	0	487
2021	1	—	0	211
2022	4	247	0	246
2023	1	—	0	209
2024	0	—	0	279
2025	0	—	2	274
2026	1	—	0	—

What is it indicated for?

The InScope, LLC rotatable snare is intended for

the electrosurgical removal and cauterization of

gastrointestinal tract polyps through an endoscope.

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/K992477 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992477: Rotosnare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992477

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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