510(k) · Cleared
ClearedUroplasty Rigid Endoscpic Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uroplasty, Inc. · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Aug 3, 2012 as substantially equivalent to K091391 (Uroplasty, Inc., 2009) after a 92-day review. Its family tree reaches back 5 generations to 1982.
- Decided
- Aug 3, 2012
- Review
- 92 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820973 (1982). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 backK051905 Uroplasty Rigid Endoscopic NeedleUroplasty, Inc. · 2005
- 1 generation backK091391 Uroplasty Rigid Endoscopic Needle, MRN-518Uroplasty, Inc. · 2009
- This deviceK121337 Uroplasty Rigid Endoscpic NeedlesUroplasty, Inc. · 2012
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 | K051905 | Uroplasty Rigid Endoscopic Needle | Uroplasty, Inc. | 2005 | — |
| −1 | K091391 | Uroplasty Rigid Endoscopic Needle, MRN-518 | Uroplasty, Inc. | 2009 | — |
| 0 (this device) | K121337 | Uroplasty Rigid Endoscpic Needles | Uroplasty, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 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? (1)
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 |
|---|---|---|---|
| * | K091391 | Uroplasty Rigid Endoscopic Needle, MRN-518Summary page 1…les Classification Name Endloscopes and accessories (21 CFR 876.1500, Product Code ERK) Legally Marketed (Predicate) Device Uroplasty Rigid Endoscopic Needles (K091391) Device Description The Uroplasty Rigid Endoscopic Needle is an accessory for endoscopes with a working channel inner diameter… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 7 ancestors has a recall.
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. 2012, 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 Uroplasty Rigid Endoscopic Needles. are accessories to currently marketed endoscopes allowing delivery of injectable material into tissues during an endoscopic procedure. The Uroplasty Rigid Endoscopic Needles may be used in a variety of endoscopic procedures for the delivery of a variety of injectable materials. The type of material to be injected will be dependent on the nature of the endoscopic procedure. Possible injectable materials include: tissue bulking agents; sclerosing agents; local anesthetics; saline; or contrast media.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121337: Uroplasty Rigid Endoscpic Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121337
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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