510(k) Report

510(k) · Cleared

Cleared

Lariat snare

K151197510(k) TraditionalCleared Jul 6, 201562-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

United States Endoscopy Group, Inc. · FDI Snare, Flexible

Cleared on Jul 6, 2015 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided
Jul 6, 2015
Review
62 days
Class
Class II
Product code
FDI
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2022: 1 descendant cleared201620182020202220242026
  1. This deviceK151197 Lariat snareUnited States Endoscopy Group, Inc. · 2015
  2. Descendant · cites it directly · 1 of its ownK183289 ClearGrasp SnareFinemedix Co., Ltd. · 2019
  3. Descendant · 2 generations on · 0 of its ownK220846 Core-SnareIncore Co., Ltd. · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K183289ClearGrasp SnareFinemedix Co., Ltd. · 2019 · cites it directly1descendant
  • K220846Core-SnareIncore Co., Ltd. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K151197Lariat snareUnited States Endoscopy Group, Inc.2015—
+1K183289ClearGrasp SnareFinemedix Co., Ltd.2019—
+2K220846Core-SnareIncore Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202210
FIG. 1 — Lineage of K151197, 2015–2022Source: 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), the FDA 510(k) statement (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. #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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K183289ClearGrasp SnareFinemedix Co., Ltd.20191

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, K183289 (Finemedix Co., Ltd., 2019) has gone furthest, with 1 descendant 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. 2015, this device’s year, is highlighted.

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—

What is it indicated for?

The Lariat snare is an electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during Gastrointestinal (GI) endoscopic procedures. The device can be used with or without monopolar diathermic energy.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K151197: Lariat snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151197

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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