510(k) · Cleared
ClearedCook Injection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Oct 25, 2002 as substantially equivalent to K982890 (Advanced Uroscience, Inc., 1998) and 4 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1982. 12 later devices descend from it.
- Decided
- Oct 25, 2002
- Review
- 88 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K820973 (1982). 8 ancestors in all, the oldest K812057 (1981). 12 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 3 generations backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- 2 generations backK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- 1 generation backK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
- This deviceK022484 Cook Injection NeedleCook Urological, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK090830 Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · Recalled
- Descendant · cites it directly · 2 of its ownK090217 Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S · 2009
- Descendant · 2 generations on · 1 of its ownK192498 Single Use InjectorOlympus Medical Systems Corp. · 2020
- Descendant · 2 generations on · 1 of its ownK180214 Repris Bladder Injection SystemUro-1, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK171602 Williams Cystoscopic Injection NeedleCook Incorporated · 2017 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · cites it directly3descendants
- K090217Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S · 2009 · cites it directly2descendants
- K192498Single Use InjectorOlympus Medical Systems Corp. · 2020 · 2 generations on1descendant
- K180214Repris Bladder Injection SystemUro-1, Inc. · 2018 · 2 generations on1descendant
- K171602Williams Cystoscopic Injection NeedleCook Incorporated · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −3 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| −2 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| −1 | K990996 | Genyx Medical Injection Needle | Genyx Medical, Inc. | 1999 | — |
| 0 (this device) | K022484 | Cook Injection Needle | Cook Urological, Inc. | 2002 | — |
| +1 | K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip | Laborie Medical Technologies, Ltd. | 2009 | 1 |
| +1 | K090217 | Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 | Coloplast A/S | 2009 | — |
| +2 | K192498 | Single Use Injector | Olympus Medical Systems Corp. | 2020 | — |
| +2 | K180214 | Repris Bladder Injection System | Uro-1, Inc. | 2018 | — |
| +1 | K171602 | Williams Cystoscopic Injection Needle | Cook Incorporated | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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…BK Predicate Devices: Specifically, the Cook Injection Needles are similar to The Advanced UroScience Injection Needles (K#982890), The Martech Endoscopic Needle (K#960519), The Genyx Medical Inj… | 1998 |
| * | K960519 | Martech Endoscopic Injection NeedleSummary page 1…les are similar to The Advanced UroScience Injection Needles (K#982890), The Martech Endoscopic Needle (K#960519), The Genyx Medical Injection Needles (K#990996), The Tunis Transurethral… | 1996 |
| * | K990996 | Genyx Medical Injection NeedleSummary page 1…tion Needles (K#982890), The Martech Endoscopic Needle (K#960519), The Genyx Medical Injection Needles (K#990996), The Tunis Transurethral InjectiodAspiration System Probe Devices (K#983765) and… | 1999 |
| * | K983765 | Injection Needle Probe/Device-TunisSummary page 1…Medical Injection Needles (K#990996), The Tunis Transurethral InjectiodAspiration System Probe Devices (K#983765) and The Vance Cystoscopic Injection Needle (K#812057). Device Description: The Cook… | 1998 |
| * | K812057 | Vance CystoscopicSummary page 1…rethral InjectiodAspiration System Probe Devices (K#983765) and The Vance Cystoscopic Injection Needle (K#812057). Device Description: The Cook Injection Needle will consist of a Polyurethane Cathe… | 1981 |
What descends from it? (12)
See all 126 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip | 2009 | 3 |
| K090217 | Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 | 2009 | 2 |
| K171602 | Williams Cystoscopic Injection Needle | 2017 | 1 |
| K221085 | LiNA OperaScope Needle | 2022 | 0 |
| K113634 | Injekt Cysto Flexible Injection Needle | 2012 | 0 |
| K082319 | Injekt Filiform Injection Needle | 2008 | 0 |
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 20 years and passes through 5 companies; a new generation was cleared every 3.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K090830 (Laborie Medical Technologies, Ltd., 2009) has gone furthest, with 3 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 Cook Injection Needles are used to deliver a variety of injectable materials into tissues during laparoscopic, hysteroscopic, cystoscopic, endoscopic transurethral procedures and open surgical procedures. The type of material to be injected will be dependent on the nature of the procedure. The needle is intended to be used with legally marketed drugs and devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022484 · printed Nov 5, 2026
Cite this page
510(k) Report. “K022484: Cook Injection Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K022484
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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