510(k) · Cleared
ClearedSclerotherapy & Endoscopic Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
G-Flex Europe Sprl · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Apr 3, 2023 as substantially equivalent to K171454 (Boston Scientific Corporation, 2017) after a 270-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 3, 2023
- Review
- 270 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K961846 (1996). 6 ancestors in all, the oldest K902736 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK961846 Needle CatheterBoston Scientific Corp · 1996
- 2 generations backK012864 Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816…Boston Scientific Corp · 2001
- 1 generation backK171454 Interject Injection Therapy Needle CatheterBoston Scientific Corporation · 2017 · Recalled
- This deviceK222006 Sclerotherapy & Endoscopic NeedlesG-Flex Europe Sprl · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961846 | Needle Catheter | Boston Scientific Corp | 1996 | — |
| −2 | K012864 | Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821… | Boston Scientific Corp | 2001 | — |
| −1 | K171454 | Interject Injection Therapy Needle Catheter | Boston Scientific Corporation | 2017 | 2 |
| 0 (this device) | K222006 | Sclerotherapy & Endoscopic Needles | G-Flex Europe Sprl | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 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? (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 |
|---|---|---|---|
| * | K171454 | Interject Injection Therapy Needle CatheterSummary page 4…ion Panel: Gastroenterology/Urology 3. PREDICATE DEVICE Primary Predicate Device: Boston Scientific, Interject Injection Therapy Needle Catheter (K171454). 4. DEVICE DESCRIPTION Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a scler… | 2017 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K171454.
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. 2023, 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?
Sclerotherapy & Endoscopic Needles are endoscopic accessories intended to introduce a sclerosing agent, vasoconstrictor,
or other solutions into selected sites to control actual or potential bleeding lesions in the digestive system or to inject
liquid to aid in polypectomy procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222006: Sclerotherapy & Endoscopic Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222006
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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