510(k) · Cleared
ClearedKARL STORZ Endoscopic Accessories for Urology
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Cleared on Jun 3, 2026 as substantially equivalent to K950434 (KARL STORZ Endoscopy-America, Inc., 1995) after a 273-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jun 3, 2026
- Review
- 273 days
- Class
- Class II
- Product code
- OCZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950434 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950434 Karl Storz Flexible Grasping, Biopsy Forceps, Stone Baskets…KARL STORZ Endoscopy-America, Inc. · 1995
- This deviceK252800 KARL STORZ Endoscopic Accessories for UrologyKarl Storz SE & CO. KG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950434 | Karl Storz Flexible Grasping, Biopsy Forceps, Stone Baskets, Dislodgers… | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| 0 (this device) | K252800 | KARL STORZ Endoscopic Accessories for Urology | Karl Storz SE & CO. KG | 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 OCZ? 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 OCZ device
- #1 K242923 SimpleSnip Endoscopic Suture Cutter…score 11.0 · 9 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K950434 | Karl Storz Flexible Grasping, Biopsy Forceps, Stone Baskets, Dislodgers, Scissors…Summary page 5…II Product Code: OCZ Classification Endoscopic Grasping/Cutting Instrument, Non-Powered Name: Device Panel: Gastroenterology/Urology Predicate K950434, KARL STORZ Flexible Accessories for Endoscopic Urology Device(s): Procedures The predicate devices… | 1995 |
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 OCZ devicesOCZ Endoscopic Grasping/Cutting Instrument, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OCZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCZ
Too few OCZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OCZ
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCZ
34in 2025
MAUDE reports naming product code OCZ, 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 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 242 |
| 2016 | 1 | — | 0 | 759 |
| 2017 | 0 | — | 0 | 734 |
| 2018 | 0 | — | 0 | 252 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 21 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 17 | 33 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The indications for use are the same for all subject devices, except for differences in which devices are indicated for use in pediatric populations. • For 11274FE, 11274ZE, 27023FM, 27095F, 27095P, 27095Z: Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy for patients from birth and older. • For 27034FK…
Read the full statement (148 words)
The indications for use are the same for all subject devices, except for differences in which devices are indicated for use in pediatric populations.
• For 11274FE, 11274ZE, 27023FM, 27095F, 27095P, 27095Z:
Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy for patients from birth and older.
• For 27034FK, 27034FL, 27034S:
Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy for patients 2 years of age and older.
• For 11275FE, 11275ZE, 27023FE, 27023ZE, 27035D, 27035F, 27035L, 27035S, 27178A, 27178B, 27424F, 27424P, 27424R, 27424U, 27424Z, 27425F, 27425FG, 27425P, 27425PG, 27425R, 27425RG, 27425U, 27425Z, 27425ZG:
Endoscopic accessories for urology are indicated for use by qualified surgeons during endoscopic surgical urology procedures, such as cystoscopy, urethroscopy, ureteroscopy and ureterorenoscopy in adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252800 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252800: KARL STORZ Endoscopic Accessories for Urology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252800
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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