510(k) · Cleared
Recalled · Class II · 2026Williams Cystoscopic Injection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Jul 28, 2017 as substantially equivalent to K022484 (Cook Urological, Inc., 2002) after a 57-day review. Its family tree reaches back 5 generations to 1982. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 28, 2017
- Review
- 57 days
- Class
- Class II
- Product code
- FBK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820973 (1982). 9 ancestors in all, the oldest K812057 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 4 generations backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- 3 generations backK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- 2 generations backK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
- 1 generation backK022484 Cook Injection NeedleCook Urological, Inc. · 2002
- This deviceK171602 Williams Cystoscopic Injection NeedleCook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK182876 Uro-N CystoscopeUroviu Corporation · 2019
Most influential descendants
Showing 1 of 1 · See all- K182876Uro-N CystoscopeUroviu Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −4 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| −3 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| −2 | K990996 | Genyx Medical Injection Needle | Genyx Medical, Inc. | 1999 | — |
| −1 | K022484 | Cook Injection Needle | Cook Urological, Inc. | 2002 | — |
| 0 (this device) | K171602 | Williams Cystoscopic Injection Needle | Cook Incorporated | 2017 | — |
| +1 | K182876 | Uro-N Cystoscope | Uroviu Corporation | 2019 | — |
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 |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K022484 | Cook Injection NeedleSummary page 4…§876.1500, Product Code FBK Device Class/Classification Panel: Class II, Gastroenterology/Urology Predicate Device: Cook Injection Needles (Cook Urological Inc., K022484) is the predicate device for the Williams Cystoscopic Injection Needle. Device Description: The Williams Cystoscopic Injection… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182876 | Uro-N Cystoscope | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2026 | Class II | Z-0163-2027 | Under Investigation by firm | The female Luer lock adapter component in the affected device lots may not have been correctly seated due to misalignment and inadequate torquing during manufacturing. Potential events that may occur as a result of this issue include… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K182876 (Uroviu Corporation, 2019) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K022484.
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. 2017, 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?
The Williams Cystoscopic Injection Needle is used for cystoscopic injection into the urethra, bladder neck, and bladder wall.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171602 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171602: Williams Cystoscopic 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/K171602
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