510(k) · Cleared
Recalled · Class II · 2023Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laborie Medical Technologies, Ltd. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Jul 21, 2009 as substantially equivalent to K043383 (Physion, Inc., 2005) and 1 other predicate after a 117-day review. Its family tree reaches back 5 generations to 1982. 3 later devices descend from it. It has been recalled once.
- Decided
- Jul 21, 2009
- Review
- 117 days
- Class
- Class II
- Product code
- FBK
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K820973 (1982). 10 ancestors in all, the oldest K812057 (1981). 3 later devices descend from it, 2 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 deviceK090830 Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK180214 Repris Bladder Injection SystemUro-1, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253598 InjecSURE Injection SystemCarbon Medical Technologies, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK241523 injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp. · 2024
Most influential descendants
Showing 3 of 3 · See all- K180214Repris Bladder Injection SystemUro-1, Inc. · 2018 · cites it directly1descendant
- K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc. · 2026 · 2 generations on0descendants
- K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp. · 2024 · 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) | K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip | Laborie Medical Technologies, Ltd. | 2009 | — |
| +1 | K180214 | Repris Bladder Injection System | Uro-1, Inc. | 2018 | — |
| +2 | K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | 2026 | — |
| +1 | K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Laborie Medical Technologies, Corp. | 2024 | — |
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 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K043383 | N-DO Endoinjector Needle, Model PH00961109 and PH00961110Summary page 1…II Product Code: FBK Predicate Devices: InjeTAKTM Adjustable Tip Needles are similar to: The N-DO Endoinjector Needle (K043383) The Cook Injection Needles (K022484), Device Description: The injeTAKTM Adjustable Tip Needle… | 2005 |
| * | K022484 | Cook Injection NeedleSummary page 1…Predicate Devices: InjeTAKTM Adjustable Tip Needles are similar to: The N-DO Endoinjector Needle (K043383) The Cook Injection Needles (K022484), Device Description: The injeTAKTM Adjustable Tip Needle consists of a metal needle cannula and an outer movabl… | 2002 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2023 | Class II | Z-1478-2023 | Process control | The packaging may be damaged, compromising the sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K180214 (Uro-1, Inc., 2018) has gone furthest, with 1 descendant 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. 2009, 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 injeTak TM Adjustable Tip Needles are intended to be used to deliver a variety of
legally marketed drugs into tissues or structures during cystoscopic procedures. They
are provided sterile and single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090830
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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