510(k) · Cleared
ClearedZamenix™ P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roen Surgical, Inc. · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Aug 7, 2026 as substantially equivalent to K233700 (Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi, 2024) after a 280-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Aug 7, 2026
- Review
- 280 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K233700 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backK233700 Avicenna RoboflexElmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi · 2024
- This deviceK253505 Zamenix™ PRoen Surgical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K233700 | Avicenna Roboflex | Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi | 2024 | — |
| 0 (this device) | K253505 | Zamenix™ P | Roen Surgical, Inc. | 2026 | — |
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 FGB? 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 FGB device
- #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 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 |
|---|---|---|---|
| * | K233700 | Avicenna RoboflexSummary page 5…d Accessories, Flexible/rigid Product Code – Device – FGB – Endoscope and accessories (21 CFR §876.1500). Regulation Number Primary K233700 Elmed Elektronik ve Medikal Sanayi ve Ticaret Anonim Sirketi Predicate Avicenna Roboflex Reference K200238… | 2024 |
| † | K200238 | ControlRad Sterile Cover | 2020 |
| † | K170898 | Wittich Nitinol Stone Basket | 2017 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FGB devicesFGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FGB
17in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGB
134in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGB
15in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGB
1,307in 2025
MAUDE reports naming product code FGB, 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 | 6 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 17 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 1 | — | 0 | 8 |
| 2014 | 2 | — | 0 | 12 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 0 | — | 0 | 35 |
| 2017 | 2 | — | 0 | 142 |
| 2018 | 4 | 191 | 0 | 118 |
| 2019 | 2 | — | 0 | 207 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 3 | 191 | 0 | 325 |
| 2022 | 5 | 205 | 4 | 455 |
| 2023 | 8 | 183 | 1 | 458 |
| 2024 | 16 | 217 | 15 | 572 |
| 2025 | 17 | 134 | 0 | 1,307 |
| 2026 | 9 | 140 | 1 | — |
What is it indicated for?
Zamenix™ P is indicated for endoscopic examination in the urinary tract with transurethral access and can be used to
examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic
procedures. The device is intended for use in patients aged 22 or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253505: Zamenix™ P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253505
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026