Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CMOS Video-Rhino-Laryngoscope System

K-Number: K182186 · 2019-03-22

Decision Date2019-03-22
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CMOS Video-Rhino-Laryngoscope System is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2019-03-22 under 510(k) 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. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K182186.

When did CMOS Video-Rhino-Laryngoscope System receive FDA 510(k) clearance?

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

Who is the listed applicant for CMOS Video-Rhino-Laryngoscope System?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 52 devices →

Related Devices (Code: EOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.