510(k) · Cleared
ClearedGenyx Medical Injection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genyx Medical, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Jun 18, 1999 as substantially equivalent to K982890 (Advanced Uroscience, Inc., 1998) after an 85-day review. Its family tree reaches back 3 generations to 1982. 13 later devices descend from it.
- Decided
- Jun 18, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K820973 (1982). 5 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 2 generations backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- 1 generation backK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- This deviceK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
- Descendant · cites it directly · 12 of its ownK022484 Cook Injection NeedleCook Urological, Inc. · 2002
- Descendant · 2 generations on · 3 of its ownK090830 Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK090217 Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S · 2009
- Descendant · 3 generations on · 1 of its ownK192498 Single Use InjectorOlympus Medical Systems Corp. · 2020
- Descendant · 3 generations on · 1 of its ownK180214 Repris Bladder Injection SystemUro-1, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K022484Cook Injection NeedleCook Urological, Inc. · 2002 · cites it directly12descendants
- K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · 2 generations on3descendants
- K090217Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S · 2009 · 2 generations on2descendants
- K192498Single Use InjectorOlympus Medical Systems Corp. · 2020 · 3 generations on1descendant
- K180214Repris Bladder Injection SystemUro-1, Inc. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −2 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| −1 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| 0 (this device) | K990996 | Genyx Medical Injection Needle | Genyx Medical, Inc. | 1999 | — |
| +1 | K022484 | Cook Injection Needle | Cook Urological, Inc. | 2002 | — |
| +2 | K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip | Laborie Medical Technologies, Ltd. | 2009 | 1 |
| +2 | K090217 | Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 | Coloplast A/S | 2009 | — |
| +3 | K192498 | Single Use Injector | Olympus Medical Systems Corp. | 2020 | — |
| +3 | K180214 | Repris Bladder Injection System | Uro-1, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K982890 | Advanced Uroscience Injection NeedleSummary page 1…ch substantial equivalence is being claimed: Company: Advanced UroScience Richard Wolf Medical Instruments Device: Injection Needle Aspiration/ Injection Needle 510(k): K982890 Pre-Amendment Date Cleared: 10/26/98 N/A 4. A description of the device that is the subject of the 510(k), including explanation… | 1998 |
| * | — | Aspiration/ Injection Needle Named without a submission number |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022484 | Cook Injection Needle | 2002 | 12 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K022484 (Cook Urological, Inc., 2002) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K982890.
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.
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?
The Genyx Injection Needle is an accessory for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990996: Genyx Medical Injection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990996
Report an extraction error
Are you the manufacturer?
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