510(k) · Cleared
ClearedAdvanced Uroscience Injection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Uroscience, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Oct 26, 1998 as substantially equivalent to K843719 (Ocean Medical Products, Ltd., 1984) and 1 other predicate after a 70-day review. Its family tree reaches back 2 generations to 1982. 20 later devices descend from it.
- Decided
- Oct 26, 1998
- Review
- 70 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K820973 (1982). 4 ancestors in all. 20 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 1 generation backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- This deviceK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- Descendant · cites it directly · 13 of its ownK990996 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 · cites it directly · 3 of its ownK051905 Uroplasty Rigid Endoscopic NeedleUroplasty, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK090217 Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S · 2009
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K990996Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999 · cites it directly13descendants
- 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
- K051905Uroplasty Rigid Endoscopic NeedleUroplasty, Inc. · 2005 · cites it directly3descendants
- K090217Bonee Needle for Bladder Injections, MODELSNBI035, NBI070Coloplast A/S · 2009 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −1 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| 0 (this device) | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| +1 | 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 |
| +1 | K051905 | Uroplasty Rigid Endoscopic Needle | Uroplasty, Inc. | 2005 | — |
| +2 | K090217 | Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 | Coloplast A/S | 2009 | — |
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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K843719 | Single Wall Introducer NeedleSummary page 1…ad St. Paul, MN 55110 651-653-8512 Karen E. Peterson Vice President of Regulatory, Clinical, and Quality Affairs Single Wall Introducer Needle, Ocean Medical Products (K843719) Martech Endoscopic Injection Needle, Martech Medical Products, Inc (K960519) 10 (75,73‘?6 /?&ng Device Descri… | 1984 |
| * | K960519 | Martech Endoscopic Injection NeedleSummary page 1…tory, Clinical, and Quality Affairs Single Wall Introducer Needle, Ocean Medical Products (K843719) Martech Endoscopic Injection Needle, Martech Medical Products, Inc (K960519) 10 (75,73‘?6 /?&ng Device Description The Advanced UroScience Injection Needle consists of a stainless steel… | 1996 |
What descends from it? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 14.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K990996 (Genyx Medical, Inc., 1999) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K843719.
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 Advanced UroScience 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/K982890 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982890: Advanced Uroscience 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/K982890
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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