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FDA 510(k)

CMOS Video Rhino-Laryngoscope SSU

K-Number: K192090 · 2020-01-27

ApplicantKarl Storz SE & CO. KG
Decision Date2020-01-27
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CMOS Video Rhino-Laryngoscope SSU is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2020-01-27 under 510(k) number K192090. 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 SSU?

CMOS Video Rhino-Laryngoscope SSU is a medical device that received FDA 510(k) clearance on 2020-01-27. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K192090.

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

CMOS Video Rhino-Laryngoscope SSU received FDA 510(k) clearance on 2020-01-27, under 510(k) number K192090.

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

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Karl Storz SE & CO. KG as applicant

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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.

K261544Hydro Irrigation SystemStryker InstrumentsK254133ENTity USB Videoscope SystemOptim, LLCK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLCK243639Portare System (FA-001)Grumpy Innovation, 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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