Cleared Traditional

K243550 - KARL STORZ Flexible Video-Uretero-Renos...

K243550 is the FDA 510(k) clearance for KARL STORZ Flexible Video-Uretero-Renos... by Karl Storz SE & CO. KG. It is a Class 2 Gastroenterology & Urology device (product code FGB) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K243550 · Karl Storz SE & CO. KG · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2025
Decision
203d
Days
Class 2
Risk

K243550 is an FDA 510(k) clearance for the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC). Classified as Ureteroscope And Accessories, Flexible/rigid (product code FGB), Class II - Special Controls.

Submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on June 6, 2025 after a review of 203 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Karl Storz SE & CO. KG devices

Submission Details

510(k) Number K243550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2024
Decision Date June 06, 2025
Days to Decision 203 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 130d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGB Ureteroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGB Ureteroscope And Accessories, Flexible/rigid

All 84
Devices cleared under the same product code (FGB) and FDA review panel - the closest regulatory comparables to K243550.
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
K252806 · Shanghai AnQing Medical Instrument Co., Ltd. · Oct 2025
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000)
K252703 · Boston Scientific Corporation · Sep 2025
Medical Video Endoscope [Standard Deflection] (URS3005)
K250049 · Seplou (Zhuhai) Co., Ltd. · Aug 2025
Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US)
K242699 · Opcom Medical, Inc. · May 2025
Single-use Flexible Ureteroscope
K250785 · Hunan Vathin Medical Instrument Co., Ltd. · May 2025
F88 URE-SD/RD Flexible Ureteroscope
K243894 · Sg Endoscopy Pte, Ltd. · May 2025