510(k) Report

510(k) · Cleared

Cleared

Snare Flexible

K924105510(k) TraditionalCleared Nov 24, 1992103-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 Nov 24, 1992 after a 103-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Nov 24, 1992
Review
103 days
Class
Class II
Product code
FDI
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared1990200020102020
  1. This deviceK924105 Snare FlexibleUnited States Endoscopy Group, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK103611 Urology Monopolar Snare for Tissue TransectionUnited States Endoscopy Group, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all
  • K103611Urology Monopolar Snare for Tissue TransectionUnited States Endoscopy Group, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924105Snare FlexibleUnited States Endoscopy Group, Inc.1992—
+1K103611Urology Monopolar Snare for Tissue TransectionUnited States Endoscopy Group, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
FIG. 1 — Lineage of K924105, 1992–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K103611Urology Monopolar Snare for Tissue TransectionUnited States Endoscopy Group, Inc.20110

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, K103611 (United States Endoscopy Group, Inc., 2011) has gone furthest, with 0 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. “K924105: Snare Flexible.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924105

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026