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 a medical device manufactured by Karl Storz Endoscopy America, Inc.. It received FDA 510(k) clearance on 2021-05-11 under approval 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. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K202272.
When was HD Mediastinoscope approved by the FDA?
HD Mediastinoscope received FDA 510(k) clearance on 2021-05-11, under approval number K202272.
What company makes HD Mediastinoscope?
HD Mediastinoscope is manufactured by Karl Storz Endoscopy America, Inc..
What is the FDA product code for HD Mediastinoscope?
The FDA product code for HD Mediastinoscope is EWY.
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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.