510(k) Report

510(k) · Cleared

Cleared

Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories

K950496510(k) TraditionalCleared Mar 30, 199552-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

Boston Scientific Corp · FDI Snare, Flexible

Cleared on Mar 30, 1995 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 19 later devices descend from it.

Decided
Mar 30, 1995
Review
52 days
Class
Class II
Product code
FDI
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared1996: 1 descendant cleared2008: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2020: 2 descendants cleared2018: 3 descendants cleared2017: 1 descendant cleared2023: 1 descendant cleared2022: 4 descendants cleared2019: 2 descendants cleared1995200020052010201520202025
  1. This deviceK950496 Snare, Flexible, Electrosurgical Cutting & Coagulation Device &…Boston Scientific Corp · 1995
  2. Descendant · cites it directly · 17 of its ownK992477 RotosnareInscope, LLC · 1999
  3. Descendant · 2 generations on · 15 of its ownK131700 Sensation Short Throw, Captiflex, Captivator, Captivator II…Boston Scientific Corp · 2013 · Recalled
  4. Descendant · 3 generations on · 10 of its ownK133987 Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · Recalled
  5. Descendant · 4 generations on · 5 of its ownK172729 Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2018
  6. Descendant · 3 generations on · 4 of its ownK160637 Rotatable SnaresBoston Scientific Corporation · 2016

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

1996: 11999: 12008: 12013: 12014: 12016: 12017: 12018: 32019: 22020: 22022: 42023: 1
1996high 4 (2022) · low 0 (1997)2026

Most influential descendants

Showing 5 of 19 · See all
  • K992477RotosnareInscope, LLC · 1999 · cites it directly17descendants
  • K131700Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use…Boston Scientific Corp · 2013 · 2 generations on15descendants
  • K133987Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · 3 generations on10descendants
  • K172729Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2018 · 4 generations on5descendants
  • K160637Rotatable SnaresBoston Scientific Corporation · 2016 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950496Snare, Flexible, Electrosurgical Cutting & Coagulation Device & AccessoriesBoston Scientific Corp1995—
+1K992477RotosnareInscope, LLC1999—
+2K131700Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile…Boston Scientific Corp20138
+3K133987Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation20141
+4K172729Polypectomy SnareHangzhou AGS MedTech Co., Ltd.2018—
+3K160637Rotatable SnaresBoston Scientific Corporation2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199910
200810
201310
201410
201610
201710
201830
201920
202020
202240
202310
FIG. 1 — Lineage of K950496, 1995–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 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. #1 K251692 Advanced Tissue Resection Devicescore 10.9 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K992477RotosnareInscope, LLC199917
K963750Retrieval SnareBoston Scientific Corp19960

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, K992477 (Inscope, LLC, 1999) has gone furthest, with 17 descendants of its own.

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

2008: 22009: 12011: 12012: 12013: 32014: 52015: 32016: 12017: 12018: 42019: 32020: 22021: 12022: 42023: 12026 (partial year): 1
2007high 5 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDI

247in 2022

2013: 87 days median2014: 47 days median2015: 62 days median2018: 214 days median2019: 100 days median2022: 247 days median
2007high 247 (2022) · low 47 (2014)2026

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

Recalls per year · FDI

2in 2025

2010: 12015: 12025: 2
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

2007: 482008: 2012009: 2652010: 1742011: 1772012: 1622013: 1912014: 3452015: 1952016: 2232017: 1542018: 1812019: 1352020: 4872021: 2112022: 2462023: 2092024: 2792025: 274
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—048
20082—0201
20091—0265
20100—1174
20111—0177
20121—0162
20133870191
20145470345
20153621195
20161—0223
20171—0154
201842140181
201931000135
20202—0487
20211—0211
202242470246
20231—0209
20240—0279
20250—2274
20261—0—
Cite this page

510(k) Report. “K950496: Snare, Flexible, Electrosurgical Cutting & Coagulation Device & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950496

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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