510(k) · Cleared
ClearedMiniature Telescope for Urology (27033AA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · FGB Ureteroscope And Accessories, Flexible/Rigid
Cleared on Nov 18, 2025 as substantially equivalent to K233372 (Karl Storz SE & CO. KG, 2024) and 1 other predicate after a 49-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Nov 18, 2025
- Review
- 49 days
- Class
- Class II
- Product code
- FGB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K940464 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK940464 Karl Storz Uretero-Renoscope/UreterscopeKARL STORZ Endoscopy-America, Inc. · 1994
- 1 generation backK233372 KARL STORZ Fiber Telescopes for UrologyKarl Storz SE & CO. KG · 2024 · Recalled
- This deviceK253411 Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG · 2025
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K233372 | KARL STORZ Fiber Telescopes for UrologySummary page 5…Flexible/Rigid Regulatory Class: II Product Code: FGB Classification Gastroenterology/Urology Panel: Predicate KARL STORZ Fiber Telescopes for Urology (K233372) Device(s): KARL STORZ Uretero Renoscopes/Ureteroscopes (K940464) Device The Miniature Telescope for Urology… | 2024 |
| * | K940464 | Karl Storz Uretero-Renoscope/UreterscopeSummary page 5…Gastroenterology/Urology Panel: Predicate KARL STORZ Fiber Telescopes for Urology (K233372) Device(s): KARL STORZ Uretero Renoscopes/Ureteroscopes (K940464) Device The Miniature Telescope for Urology (27033AA) is a semi-rigid telescope that Description: utilizes fibe… | 1994 |
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 31 years and passes through 2 companies; a new generation was cleared every 30.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
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. 2025, 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?
The endoscopes when used with sheaths and obturators are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics.
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/K253411 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253411: Miniature Telescope for Urology (27033AA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253411
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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