Cleared Special

K212476 - KARL STORZ Flexible HD Cysto-Urethroscope System

K212476 is an FDA 510(k) clearance for KARL STORZ Flexible HD Cysto-Urethrosco..., manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FAJ cleared through the Special 510(k) pathway after a 28-day FDA review.

K212476 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
28d
Days
Class 2
Risk

K212476 is an FDA 510(k) clearance for the KARL STORZ Flexible HD Cysto-Urethroscope System. 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 September 3, 2021 after a review of 28 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.

FDA 510(k) Submission Details - K212476

510(k) Number K212476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2021
Decision Date September 03, 2021
Days to Decision 28 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
103d faster than avg
Panel avg: 131d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

FAJ Device Classification - Class 2, Special Controls

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 92
Devices cleared under the same product code (FAJ) and FDA review panel - the closest regulatory comparables to K212476.
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K222162 · Shanghai AnQing Medical Instrument Co., Ltd. · Nov 2022
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K222602 · Zhuhai Pusen Medical Technology Co., Ltd. · Sep 2022
WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System
K212202 · OTU Medical, Inc. · Apr 2022
LUMINELLE DTx System
K210512 · Uvision360, Inc. · Jun 2021
Uro-G Cystoscope
K202921 · Uroviu Corporation · May 2021
Flexible Video Cysto-Urethroscope (C-view)
K202957 · KARL STORZ Endoscopy-America, Inc. · Oct 2020
K212476 · KARL STORZ Flexible HD Cysto-Urethroscope System
Download PDF FDA Summary KARL STORZ Endoscopy-…