510(k) · Cleared
ClearedInjector Needle/Snare
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 Jul 8, 2004 after an 86-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 24 later devices descend from it.
- Decided
- Jul 8, 2004
- Review
- 86 days
- Class
- Class II
- Product code
- FDI
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK040961 Injector Needle/SnareUnited States Endoscopy Group, Inc. · 2004
- Descendant · cites it directly · 13 of its ownK092090 Erbelift Hand Pump and Flexible ProbeByrne Medical, Inc. · 2009
- Descendant · 2 generations on · 12 of its ownK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK111495 Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK150852 SIC 8000Cosmo Technologies, Ltd. · 2015
- Descendant · 3 generations on · 7 of its ownK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K092090Erbelift Hand Pump and Flexible ProbeByrne Medical, Inc. · 2009 · cites it directly13descendants
- K143306ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015 · 2 generations on12descendants
- K111495Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc. · 2011 · cites it directly9descendants
- K150852SIC 8000Cosmo Technologies, Ltd. · 2015 · 2 generations on8descendants
- K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040961 | Injector Needle/Snare | United States Endoscopy Group, Inc. | 2004 | — |
| +1 | K092090 | Erbelift Hand Pump and Flexible Probe | Byrne Medical, Inc. | 2009 | — |
| +2 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 | — |
| +1 | K111495 | Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K | Wilson-Cook Medical, Inc. | 2011 | — |
| +2 | K150852 | SIC 8000 | Cosmo Technologies, Ltd. | 2015 | — |
| +3 | K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 7 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 0 |
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K092090 (Byrne Medical, Inc., 2009) has gone furthest, with 13 descendants of its own.
How does its category compare?
All FDI devicesFDI Snare, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 dual lumen Injector Needle Share is indicated for use with an Olympus or Microvasive active cord for the injection of media for submucosal lift of polyps or other mucosal lesions, using diredt visualization, thmough a flexible endoscope, prior to electrosurgical excision arid for the infusion of fluid for clearing away the field of view, applying dye spray, clot removal, injection of hemostatic agents to control post-polypectomy bleeding, and tattooing of sites for future surgical purposes.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K040961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040961: Injector Needle/Snare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040961
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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