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FDA 510(k)

Flexible Video-Uretero-Renoscope SSU System

K-Number: K212458 · 2022-01-20

ApplicantKarl Storz Endoscopy America
Decision Date2022-01-20
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Flexible Video-Uretero-Renoscope SSU System is a medical device manufactured by Karl Storz Endoscopy America. It received FDA 510(k) clearance on 2022-01-20 under approval number K212458. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flexible Video-Uretero-Renoscope SSU System?

Flexible Video-Uretero-Renoscope SSU System is a medical device that received FDA 510(k) clearance on 2022-01-20. It is manufactured by Karl Storz Endoscopy America. The 510(k) number is K212458.

When was Flexible Video-Uretero-Renoscope SSU System approved by the FDA?

Flexible Video-Uretero-Renoscope SSU System received FDA 510(k) clearance on 2022-01-20, under approval number K212458.

What company makes Flexible Video-Uretero-Renoscope SSU System?

Flexible Video-Uretero-Renoscope SSU System is manufactured by Karl Storz Endoscopy America.

What is the FDA product code for Flexible Video-Uretero-Renoscope SSU System?

The FDA product code for Flexible Video-Uretero-Renoscope SSU System is FGB.

Related Clinical Trials

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Karl Storz Endoscopy America

K201526TIPCAM1 Rubina Video Endoscope System K212656Flexible Intubation Video Endoscope – Sterile (FIVE-S) K212695KARL STORZ ICG Imaging System K201001Modulith SLX-F2

Related Devices (Code: FGB)

K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K181977WiScope Digital Endoscope SystemOTU Medical, Inc. K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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