510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Proposed Trademan Microvasive Polypectomy Snares

K941750510(k) TraditionalCleared Nov 1, 1994207-day reviewClass II21 CFR 876.4300Recalls 3

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 Nov 1, 1994 after a 207-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled 3 times.

Decided
Nov 1, 1994
Review
207 days
Class
Class II
Product code
FDI
Recalls
3
Predicates
0

18 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2013: 1 descendant cleared1996: 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 cleared1990200020102020
  1. This deviceK941750 Proposed Trademan Microvasive Polypectomy SnaresBoston Scientific Corp · 1994
  2. Descendant · cites it directly · 15 of its ownK131700 Sensation Short Throw, Captiflex, Captivator, Captivator II…Boston Scientific Corp · 2013 · Recalled
  3. Descendant · 2 generations on · 10 of its ownK133987 Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation · 2014 · Recalled
  4. Descendant · 3 generations on · 5 of its ownK172729 Polypectomy SnareHangzhou AGS MedTech Co., Ltd. · 2018
  5. Descendant · 2 generations on · 4 of its ownK160637 Rotatable SnaresBoston Scientific Corporation · 2016
  6. Descendant · 3 generations on · 3 of its ownK172758 Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd. · 2018

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

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

Most influential descendants

Showing 5 of 18 · 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K941750Proposed Trademan Microvasive Polypectomy SnaresBoston Scientific Corp1994—
+1K131700Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile…Boston Scientific Corp20138
+2K133987Captivator II,Single-Use Polypectomy SnaresBoston Scientific Corporation20141
+3K172729Polypectomy SnareHangzhou AGS MedTech Co., Ltd.2018—
+2K160637Rotatable SnaresBoston Scientific Corporation2016—
+3K172758Rotatable Snares, Non-Rotatable SnaresZhejiang Chuangxiang Medical Technology Co., Ltd.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200810
201310
201410
201610
201710
201830
201920
202020
202240
202310
FIG. 1 — Lineage of K941750, 1994–2023Source: 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
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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? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K131700Sensation Short Throw, Captiflex, Captivator, Captivator II, Profile, Single-Use…Boston Scientific Corp201315
K073288Ethicon Endo Surgery Articulating SnareEthicon Endo-Surgery, Inc.20080
K963750Retrieval SnareBoston Scientific Corp19960

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

Recalls of this device

DateClassRecallRoot causeReason
May 16, 2012Class IIZ-1850-2012Process controlDifficulty in extending snare loop from the catheter
May 16, 2012Class IIZ-1852-2012Process controlDifficulty in extending snare loop from the catheter
May 16, 2012Class IIZ-1851-2012Process controlDifficulty in extending snare loop from the catheter

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K131700 (Boston Scientific Corp, 2013) has gone furthest, with 15 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. “K941750: Proposed Trademan Microvasive Polypectomy Snares.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941750

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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