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FDA 510(k)

KARL STORZ Flexible HD Cysto-Urethroscope System

K-Number: K212476 · 2021-09-03

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2021-09-03
Product CodeFAJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Flexible HD Cysto-Urethroscope System is a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2021-09-03 under approval number K212476. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ Flexible HD Cysto-Urethroscope System?

KARL STORZ Flexible HD Cysto-Urethroscope System is a medical device that received FDA 510(k) clearance on 2021-09-03. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K212476.

When was KARL STORZ Flexible HD Cysto-Urethroscope System approved by the FDA?

KARL STORZ Flexible HD Cysto-Urethroscope System received FDA 510(k) clearance on 2021-09-03, under approval number K212476.

What company makes KARL STORZ Flexible HD Cysto-Urethroscope System?

KARL STORZ Flexible HD Cysto-Urethroscope System is manufactured by Karl Storz Endoscopy America, Inc..

What is the FDA product code for KARL STORZ Flexible HD Cysto-Urethroscope System?

The FDA product code for KARL STORZ Flexible HD Cysto-Urethroscope System is FAJ.

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Related Devices (Code: FAJ)

K160766Ambu USR, Ambu MAmbu A/S K170862Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree CystoscopeSolace Therapeutics, Inc. K171336Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope SheathHenke-Sass, Wolf GmbH K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc. K171500Uro-V CystoscopeUroviu Corporation K191357Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.

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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