510(k) · Cleared
ClearedN-DO Endoinjector Needle, Model PH00961109 and PH00961110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physion, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Oct 27, 2005 after a 322-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Oct 27, 2005
- Review
- 322 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK043383 N-DO Endoinjector Needle, Model PH00961109 and PH00961110Physion, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK090830 Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK180214 Repris Bladder Injection SystemUro-1, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK253598 InjecSURE Injection SystemCarbon Medical Technologies, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241523 injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp. · 2024
Most influential descendants
Showing 4 of 4 · See all- K090830Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipLaborie Medical Technologies, Ltd. · 2009 · cites it directly3descendants
- K180214Repris Bladder Injection SystemUro-1, Inc. · 2018 · 2 generations on1descendant
- K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc. · 2026 · 3 generations on0descendants
- K241523injeTAK Adjustable Tip Needle (DIS199; DIS201)Laborie Medical Technologies, Corp. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043383 | N-DO Endoinjector Needle, Model PH00961109 and PH00961110 | Physion, Inc. | 2005 | — |
| +1 | K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip | Laborie Medical Technologies, Ltd. | 2009 | 1 |
| +2 | K180214 | Repris Bladder Injection System | Uro-1, Inc. | 2018 | — |
| +3 | K253598 | InjecSURE Injection System | Carbon Medical Technologies, Inc. | 2026 | — |
| +2 | K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201) | Laborie Medical Technologies, Corp. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites 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 |
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, K090830 (Laborie Medical Technologies, Ltd., 2009) has gone furthest, with 3 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 | — |
What is it indicated for?
The N-DO Endoinjector Needles are intended to deliver a variety of legally marketed materials into the urethra, prostate and vesical cavities with visualization via a cystoscope.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K043383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043383: N-DO Endoinjector Needle, Model PH00961109 and PH00961110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043383
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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