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FDA 510(k)

HD Mediastinoscope

K-Number: K202272 · 2021-05-11

ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2021-05-11
Product CodeEWY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HD Mediastinoscope 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 2021-05-11 under 510(k) number K202272. The device is classified under product code EWY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD Mediastinoscope?

HD Mediastinoscope is a medical device that received FDA 510(k) clearance on 2021-05-11. The listed applicant is Karl Storz Endoscopy America, Inc.. The 510(k) number is K202272.

When did HD Mediastinoscope receive FDA 510(k) clearance?

HD Mediastinoscope received FDA 510(k) clearance on 2021-05-11, under 510(k) number K202272.

Who is the listed applicant for HD Mediastinoscope?

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 HD Mediastinoscope?

The FDA product code for HD Mediastinoscope is EWY.

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

View all 52 devices →

Related Devices (Code: EWY)

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.

K260003KARL STORZ Mediastinoscopes and InstrumentsKarl Storz SE & CO. KGK213194HD MediastinoscopeKarl Storz Endoscopy America, Inc.K170757Aegis Transit SystemBoston-Biomedical AssociatesK160171Illuminated Mediastinal Access PortAegis Surgical, Ltd.

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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