510(k) · Cleared
ClearedEndoscopic Injection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mill-Rose Laboratory · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Apr 16, 1982 after a 10-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.
- Decided
- Apr 16, 1982
- Review
- 10 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- Descendant · cites it directly · 21 of its ownK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- Descendant · 2 generations on · 20 of its ownK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- Descendant · 3 generations on · 13 of its ownK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
- Descendant · 2 generations on · 12 of its ownK022484 Cook Injection NeedleCook Urological, Inc. · 2002
- Descendant · 3 generations on · 3 of its ownK090830 Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K960519Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996 · cites it directly21descendants
- K982890Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998 · 2 generations on20descendants
- K990996Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999 · 3 generations on13descendants
- K022484Cook Injection NeedleCook Urological, Inc. · 2002 · 2 generations on12descendants
- K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| +1 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| +2 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| +3 | K990996 | Genyx Medical Injection Needle | Genyx Medical, Inc. | 1999 | — |
| +2 | K022484 | Cook Injection Needle | Cook Urological, Inc. | 2002 | — |
| +3 | K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip | Laborie Medical Technologies, Ltd. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (23)
See all 232 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?
- Of its descendants, K960519 (Martech Medical Products, Inc., 1996) has gone furthest, with 21 descendants of its own.
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 | — |
https://510kreport.com/device/K820973 · printed Nov 4, 2026
Cite this page
510(k) Report. “K820973: Endoscopic 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/K820973
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026