510(k) · Cleared
ClearedCook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Jul 19, 2011 as substantially equivalent to K040961 (United States Endoscopy Group, Inc., 2004) and 1 other predicate after a 49-day review. Its family tree reaches back 5 generations to 1995. 9 later devices descend from it.
- Decided
- Jul 19, 2011
- Review
- 49 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K935844 (1995). 8 ancestors in all, the oldest K934356 (1994). 9 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK935844 Gip/Medi-Globe Needle System for Ultrasonic FnaMedi-Globe Corp. · 1995
- 4 generations backK990220 Modification of Gip/Medi-Globe Ultrasound Needle SystemMedi-Globe Corp. · 1999
- 3 generations backK051247 Sonotip II Ultrasound Needle SystemMedi-Globe Corp. · 2005
- 2 generations backK070129 Sonotip II Ultrasound Needle SystemMedi-Globe Corporation · 2007
- 1 generation backK083330 Echotip Ultra Ultrasound NeedleCook Endoscopy · 2009
- This deviceK111495 Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KWilson-Cook Medical, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK150852 SIC 8000Cosmo Technologies, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK220434 Blue Eye (TS-905)The Standard Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK191923 EverLift Submucosal Lifting AgentGi Supply · 2020
- Descendant · 2 generations on · 1 of its ownK191254 EndoClotEndoclot Plus Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK180068 ORISE GelBoston Scientific · 2018 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K150852SIC 8000Cosmo Technologies, Ltd. · 2015 · cites it directly8descendants
- K220434Blue Eye (TS-905)The Standard Co., Ltd. · 2022 · 2 generations on1descendant
- K191923EverLift Submucosal Lifting AgentGi Supply · 2020 · 2 generations on1descendant
- K191254EndoClotEndoclot Plus Co., Ltd. · 2020 · 2 generations on1descendant
- K180068ORISE GelBoston Scientific · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935844 | Gip/Medi-Globe Needle System for Ultrasonic Fna | Medi-Globe Corp. | 1995 | — |
| −4 | K990220 | Modification of Gip/Medi-Globe Ultrasound Needle System | Medi-Globe Corp. | 1999 | — |
| −3 | K051247 | Sonotip II Ultrasound Needle System | Medi-Globe Corp. | 2005 | — |
| −2 | K070129 | Sonotip II Ultrasound Needle System | Medi-Globe Corporation | 2007 | — |
| −1 | K083330 | Echotip Ultra Ultrasound Needle | Cook Endoscopy | 2009 | — |
| 0 (this device) | K111495 | Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K | Wilson-Cook Medical, Inc. | 2011 | — |
| +1 | K150852 | SIC 8000 | Cosmo Technologies, Ltd. | 2015 | — |
| +2 | K220434 | Blue Eye (TS-905) | The Standard Co., Ltd. | 2022 | — |
| +2 | K191923 | EverLift Submucosal Lifting Agent | Gi Supply | 2020 | — |
| +2 | K191254 | EndoClot | Endoclot Plus Co., Ltd. | 2020 | — |
| +2 | K180068 | ORISE Gel | Boston Scientific | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 FBK? 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 FBK device
- #1 K253598 InjecSURE Injection Systemscore 12.9 · 7 generations · 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 |
|---|---|---|---|
| * | K040961 | Injector Needle/SnareSummary page 1…21 CIFR § 876.1500 PREDICATE DEVICES: US Endoscopy Dual Lumen Injector Needle Snare (k040961) Cook Endoscopic Ultra Ultrasound Needle (k083330) .… | 2004 |
| * | K083330 | Echotip Ultra Ultrasound NeedleSummary page 1…nare (k040961) Cook Endoscopic Ultra Ultrasound Needle (k083330) .TENDED USE: This device is indicated for sub mucosal lift of pol… | 2009 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150852 | SIC 8000 | 2015 | 8 |
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K150852 (Cosmo Technologies, Ltd., 2015) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K040961.
How does its category compare?
All FBK devicesFBK Endoscopic Injection Needle, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FBK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBK
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBK
9in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBK
81in 2025
MAUDE reports naming product code FBK, 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 | 3 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 4 | 101 | 0 | 12 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 9 |
| 2015 | 3 | 103 | 0 | 4 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 3 | 51 | 0 | 27 |
| 2018 | 2 | — | 0 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 20 | 34 |
| 2022 | 6 | 213 | 8 | 80 |
| 2023 | 3 | 177 | 1 | 60 |
| 2024 | 4 | 192 | 9 | 94 |
| 2025 | 3 | 155 | 0 | 81 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
This device is indicated for submucosal lift of polyps or other gastrointestinal mucosal lesions,
prior to excision with a snare or endoscopic device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111495 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111495: Cook GI Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111495
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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