510(k) · Cleared
ClearedKARL STORZ Urological Laser Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · GEX Powered Laser Surgical Instrument
Cleared on Sep 8, 2023 as substantially equivalent to K942786 (KARL STORZ Endoscopy-America, Inc., 1994) after a 193-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 8, 2023
- Review
- 193 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942786 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK942786 Karl Storz Laser AccessoriesKARL STORZ Endoscopy-America, Inc. · 1994 · Recalled
- This deviceK230535 KARL STORZ Urological Laser AccessoriesKarl Storz SE & CO. KG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942786 | Karl Storz Laser Accessories | KARL STORZ Endoscopy-America, Inc. | 1994 | 1 |
| 0 (this device) | K230535 | KARL STORZ Urological Laser Accessories | Karl Storz SE & CO. KG | 2023 | — |
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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K942786 | Karl Storz Laser AccessoriesSummary page 5…ermatology (21 CFR Part 878.4810) Common Name: Powered Laser Surgical Instrument Device Panel: Gastroenterology & Urology Predicate Device(s): K942786: KARL STORZ Laser Accessories Device Description: KARL STORZ Urological Laser Accessories are manually operated reusable… | 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?
- Its one ancestor has a recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The KARL STORZ Urological Laser Accessories are used with laser fibers during urological endoscopic procedures.
The above indications are applicable to the following model numbers:
27026 VA
27026 VI
27026 VIL
27026 OV
27026 VS
27040 SL
27040 SD
27050 SL
27050 SC
27040 XA
27040 XAL
PV27040 XAL-1
27050 CA
27050 XA
27056 LA
27056 LB
27056 LE
27056 EA
27056 EB
27056 EC
27056 ED
27068 CD
27050 VL
27040 OC
27048 CK
27050 BE
27050 BK
27051 B
27500
27502
27026 VY
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230535 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230535: KARL STORZ Urological Laser Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230535
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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