Cleared Special

K202957 - Flexible Video Cysto-Urethroscope (C-view)

K202957 is the FDA 510(k) clearance for Flexible Video Cysto-Urethroscope (C-view) by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FAJ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K202957 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 2020
Decision
29d
Days
Class 2
Risk

K202957 is an FDA 510(k) clearance for the Flexible Video Cysto-Urethroscope (C-view). Classified as Cystoscope And Accessories, Flexible/rigid (product code FAJ), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on October 29, 2020 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K202957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2020
Decision Date October 29, 2020
Days to Decision 29 days
Submission Type Special
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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FAJ Cystoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine And Perform 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 - FAJ Cystoscope And Accessories, Flexible/rigid

All 62
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K202957.
KARL STORZ Flexible HD Cysto-Urethroscope System
K212476 · KARL STORZ Endoscopy-America, Inc. · Sep 2021
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Uro-G Cystoscope
K202921 · Uroviu Corporation · May 2021
Ambu aScope 4 Cysto
K193095 · Ambu A/S · Apr 2020
Flexible HD Cysto-Urethroscope System
K191357 · KARL STORZ Endoscopy-America, Inc. · Sep 2019
Uro-N Cystoscope
K182876 · Uroviu Corporation · Jul 2019