510(k) · Cleared
ClearedGastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical Inc./Cook Endoscopy · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Dec 19, 2019 as substantially equivalent to K941305 (Wilson-Cook Medical, Inc., 1994) after a 262-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Dec 19, 2019
- Review
- 262 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941305 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941305 Wilson-Cook Variable Length GI Injection NeedleWilson-Cook Medical, Inc. · 1994 · Recalled
- This deviceK190829 Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)Wilson-Cook Medical Inc./Cook Endoscopy · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941305 | Wilson-Cook Variable Length GI Injection Needle | Wilson-Cook Medical, Inc. | 1994 | 1 |
| 0 (this device) | K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) | Wilson-Cook Medical Inc./Cook Endoscopy | 2019 | — |
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? (1)
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 |
|---|---|---|---|
| * | K941305 | Wilson-Cook Variable Length GI Injection NeedleSummary page 4…anel: Gastroenterology-Urology Procode: FBK Predicate Device: Wilson-Cook Variable Length GI Injection Needle, K941305/A, cleared June 2, 1994 Intended Use: This device is used for endoscopic injection into gastroi… | 1994 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K941305.
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. 2019, 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 used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190829: Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190829
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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