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FDA 510(k)

KARL STORZ Slim Nasopharyngolaryngoscope

K-Number: K171402 · 2018-02-02

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2018-02-02
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KARL STORZ Slim Nasopharyngolaryngoscope 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 2018-02-02 under 510(k) number K171402. 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 KARL STORZ Slim Nasopharyngolaryngoscope?

KARL STORZ Slim Nasopharyngolaryngoscope is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K171402.

When did KARL STORZ Slim Nasopharyngolaryngoscope receive FDA 510(k) clearance?

KARL STORZ Slim Nasopharyngolaryngoscope received FDA 510(k) clearance on 2018-02-02, under 510(k) number K171402.

Who is the listed applicant for KARL STORZ Slim Nasopharyngolaryngoscope?

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 KARL STORZ Slim Nasopharyngolaryngoscope?

The FDA product code for KARL STORZ Slim Nasopharyngolaryngoscope 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.

PMA P050027Light source system, diagnostic endoscopicK252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII System

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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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