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FDA 510(k)

CMOS Video-Rhino-Laryngoscope System

K-Number: K182186 · 2019-03-22

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2019-03-22
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CMOS Video-Rhino-Laryngoscope System is a medical device manufactured by KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2019-03-22 under approval number K182186. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMOS Video-Rhino-Laryngoscope System?

CMOS Video-Rhino-Laryngoscope System is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K182186.

When was CMOS Video-Rhino-Laryngoscope System approved by the FDA?

CMOS Video-Rhino-Laryngoscope System received FDA 510(k) clearance on 2019-03-22, under approval number K182186.

What company makes CMOS Video-Rhino-Laryngoscope System?

CMOS Video-Rhino-Laryngoscope System is manufactured by KARL STORZ Endoscopy-America, Inc..

What is the FDA product code for CMOS Video-Rhino-Laryngoscope System?

The FDA product code for CMOS Video-Rhino-Laryngoscope System is EOB.

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, Inc.

K161112KARL STORZ Flexible Video-Neuro-Endoscope System K152583KARL STORZ Endoscopic ICG Imaging System K171717AUTOCON III 400 K171238KARL STORZ ICG Imaging System K170462KARL STORZ ShuntScope K161554ENDOFLATOR 40, ENDOFLATOR 50

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Related Devices (Code: EOB)

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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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