510(k) · Cleared
ClearedMartech Endoscopic Injection Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Martech Medical Products, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on May 1, 1996 as substantially equivalent to K933815 (C.R. Bard, Inc., 1993) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1982. 21 later devices descend from it.
- Decided
- May 1, 1996
- Review
- 86 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K820973 (1982). 2 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- This deviceK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- Descendant · cites it directly · 20 of its ownK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- Descendant · 2 generations on · 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 · 2 generations on · 3 of its ownK051905 Uroplasty Rigid Endoscopic NeedleUroplasty, Inc. · 2005
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K982890Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998 · cites it directly20descendants
- K990996Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999 · 2 generations on13descendants
- 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 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| 0 (this device) | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| +1 | 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 | — |
| +2 | K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip | Laborie Medical Technologies, Ltd. | 2009 | 1 |
| +2 | K051905 | Uroplasty Rigid Endoscopic Needle | Uroplasty, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K933815 | Bard Endoscopic Injection System Our OCR of the scanned summary read K933812, FDA’s number for Advanced Surgical, Inc. Cannula Cleaning Device and… (Advanced Surgical, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bard Endoscopic Injection Needle”. | 1993 |
| * | K820973 | Endoscopic Injection NeedleSummary page 1…MAY -1 199 Martech Endoscopic Injection Needle 510(k) Summary Predicate Devices: Bard Endoscopic Injection Needle (K933812) and Mill-Rose Endoscopic Injection Needle (K820973) Intended Use of the Device: The Martech Endoscopic Injection Needle is indicated for use as an accessory for currently markete… | 1982 |
What descends from it? (21)
See all 212 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K982890 (Advanced Uroscience, Inc., 1998) has gone furthest, with 20 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 Martech Endoscopic Injection Needle is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures. As with currently marketed endoscopic injection needles, the Martech Endoscopic Injection Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The…
Read the full statement (125 words)
The Martech Endoscopic Injection Needle is indicated for use as an accessory for currently marketed endoscopes to provide for delivery of injectable materials into tissues during endoscopic procedures.
As with currently marketed endoscopic injection needles, the Martech Endoscopic Injection Needle may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials which have received approval for use by the FDA. The type of material to be injected will be dependent on the nature of the endoscopic procedure, but such materials may include for example: delivery of collagen during cystoscopic procedures; delivery of sclerosing agents during esophagoscopic and gastroscopic procedures; delivery of local anesthetics during cystoscopic or laryngoscopic procedures; or delivery of saline or contrast media during colonoscopic procedures.
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/K960519 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960519: Martech Endoscopic 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/K960519
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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