510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

KARL STORZ Fiber Telescopes for Urology

K233372510(k) TraditionalCleared Jul 25, 2024297-day reviewClass II21 CFR 876.1500Recalls 14

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Karl Storz SE & CO. KG · FGB Ureteroscope And Accessories, Flexible/Rigid

Cleared on Jul 25, 2024 as substantially equivalent to K940464 (KARL STORZ Endoscopy-America, Inc., 1994) after a 297-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled 14 times.

Decided
Jul 25, 2024
Review
297 days
Class
Class II
Product code
FGB
Recalls
14
Predicates
1

Its longest line of descent runs back 1 generation to K940464 (1994). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2025: 1 descendant clearedK940464 · Karl Storz Uretero-Renoscope/Ureterscope · KARL STORZ Endoscopy-America, Inc. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant K940464 · Karl Storz Uretero-Renoscope/Ureterscope · KARL STORZ Endoscopy-America, Inc. · 19940
  1. Root · 1 generation backK940464 Karl Storz Uretero-Renoscope/UreterscopeKARL STORZ Endoscopy-America, Inc. · 1994
  2. This deviceK233372 KARL STORZ Fiber Telescopes for UrologyKarl Storz SE & CO. KG · 2024
  3. Descendant · cites it directly · 0 of its ownK253411 Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K253411Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K940464Karl Storz Uretero-Renoscope/UreterscopeKARL STORZ Endoscopy-America, Inc.1994—
0 (this device)K233372KARL STORZ Fiber Telescopes for UrologyKarl Storz SE & CO. KG2024—
+1K253411Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202510
FIG. 1 — Lineage of K233372, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251951 Single-Use Video Flexible Ureterorenoscope…score 16.2 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K940464Karl Storz Uretero-Renoscope/Ureterscope
Summary page 4
…876.1500) Regulatory Class: II Product Code: FGB Classification Gastroenterology/Urology Panel: Predicate KARL STORZ Uretero Renoscopes/Ureteroscopes (K940464) Device(s): Device KARL STORZ Fiber Telescopes for Urology are manually operated reusable Description: surgical…
KARL STORZ Endoscopy-America, Inc.1994—

Also cleared against K940464: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K253411Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG20250

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 19, 2024Class IIZ-1052-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1051-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1053-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1054-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1055-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1058-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1059-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1061-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1056-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1057-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1060-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1062-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1063-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
Dec 19, 2024Class IIZ-1064-2025Labeling Change ControlScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

The 5 latest of 14 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K253411 (Karl Storz SE & CO. KG, 2025) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K940464.

How does its category compare?

All FGB devices

FGB Ureteroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · FGB

17in 2025

2012: 22013: 12014: 22015: 12017: 22018: 42019: 22020: 22021: 32022: 52023: 82024: 162025: 172026 (partial year): 9
2007high 17 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGB

134in 2025

2018: 191 days median2021: 191 days median2022: 205 days median2023: 183 days median2024: 217 days median2025: 134 days median2026 (partial year): 140 days median
2007high 217 (2024) · low 134 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGB

15in 2024

2022: 42023: 12024: 152026 (partial year): 1
2007high 15 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGB

1,307in 2025

2007: 62008: 72009: 42010: 202011: 172012: 112013: 82014: 122015: 162016: 352017: 1422018: 1182019: 2072020: 4022021: 3252022: 4552023: 4582024: 5722025: 1,307
2007high 1,307 (2025) · low 4 (2009)2025

MAUDE reports naming product code FGB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—06
20080—07
20090—04
20100—020
20110—017
20122—011
20131—08
20142—012
20151—016
20160—035
20172—0142
201841910118
20192—0207
20202—0402
202131910325
202252054455
202381831458
20241621715572
20251713401,307
202691401—

What is it indicated for?

For devices (27033C, 27033CR, 27033D, 27033F, 27033CRO, 27033CO, 27033DO, 27001E, 27001G, 27001GH, 27001GF, 27014Y) The sheaths, obturators, and accessories when used with compatible endoscopes are intended to provide visualization and access to operative site during minimal invasive urological endoscopic procedures in adults and pediatrics. For telescopes (27000K, 27000L, 27010K, 27010L, 27002KP, 27030KA, 27030KB) The endoscopes are intended to provide…

Read the full statement (102 words)

For devices (27033C, 27033CR, 27033D, 27033F, 27033CRO, 27033CO, 27033DO, 27001E, 27001G, 27001GH, 27001GF, 27014Y)

The sheaths, obturators, and accessories when used with compatible endoscopes are intended to provide visualization and access to operative site during minimal invasive urological endoscopic procedures in adults and pediatrics.

For telescopes (27000K, 27000L, 27010K, 27010L, 27002KP, 27030KA, 27030KB)

The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics.

For telescopes (27001K, 27001L, 27002K, 27002L, 27003L, 27011K, 27011L)

The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults.

Indications for use as stated in the FDA summary.

Also cleared against K940464

2 other devices cite the same predicate.

  • K253411Miniature Telescope for Urology (27033AA)Karl Storz SE & CO. KG · 2025
  • K96385512 Ureteroscopes/Uretero-RenoscopesRichard Wolf Medical Instruments Corp. · 1997

More from Karl Storz SE & CO. KG

33 FDA decisions under this applicant name. See the company

  • K260581KARL STORZ Flexible Video Neuro-EndoscopeKarl Storz SE & CO. KG · 2026
  • K254252UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver…Karl Storz SE & CO. KG · 2026
  • K254303Karl Storz SupraloopKarl Storz SE & CO. KG · 2026
  • K261102UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K254299CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION…Karl Storz SE & CO. KG · 2026

Recent decisions in FGB

The FGB category page

  • K260708Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed…Vein 360 · 2026
  • K261447CVAC® Aspiration SystemCalyxo, Inc. · 2026
  • K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd. · 2026
  • K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation · 2026
  • K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K233372 · printed Nov 4, 2026

Cite this page

510(k) Report. “K233372: KARL STORZ Fiber Telescopes 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/K233372

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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