510(k) · Cleared
ClearedUrology Monopolar Snare for Tissue Transection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Endoscopy Group, Inc. · FDI Snare, Flexible
Cleared on May 9, 2011 as substantially equivalent to K924105 (United States Endoscopy Group, Inc., 1992) and 1 other predicate after a 151-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- May 9, 2011
- Review
- 151 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924105 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK924105 Snare FlexibleUnited States Endoscopy Group, Inc. · 1992
- This deviceK103611 Urology Monopolar Snare for Tissue TransectionUnited States Endoscopy Group, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924105 | Snare Flexible | United States Endoscopy Group, Inc. | 1992 | — |
| 0 (this device) | K103611 | Urology Monopolar Snare for Tissue Transection | United States Endoscopy Group, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K924105 | Snare FlexibleSummary page 1…he device that is substantially equivalent to US Endoscopy's Urology Monopolar Snare is US Endoscopy Flexible Snare, cleared on 11-24-1992 under 5 10(k) Accession number K924105 and the Cook Urological Endosnare cleared on 6-07-1993 under 510(k) Accession number K92303 1. Device Comparison… | 1992 |
| * | K923031 | EndosnareSummary page 1…doscopy Flexible Snare, cleared on 11-24-1992 under 5 10(k) Accession number K924105 and the Cook Urological Endosnare cleared on 6-07-1993 under 510(k) Accession number K92303 1. Device Comparison Table Features Proposed Flexible Snare Cook Medical… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FDI
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FDI
247in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDI
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDI
274in 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 Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103611: Urology Monopolar Snare for Tissue Transection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103611
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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