HD Mediastinoscope
K-Number: K213194 · 2022-06-23
ApplicantKarl Storz Endoscopy America, Inc.
Decision Date2022-06-23
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 2022-06-23 under approval number K213194. 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 2022-06-23. It is manufactured by Karl Storz Endoscopy America, Inc.. The 510(k) number is K213194.
When was HD Mediastinoscope approved by the FDA?
HD Mediastinoscope received FDA 510(k) clearance on 2022-06-23, under approval number K213194.
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.
Other Devices by Karl Storz Endoscopy America, Inc.
K161555KARL STORZ NAV1 Electromagnetic Navigation System
K160044Image1 SPIES System
K150969Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
K162992Karl Storz UROMAT E.A.S.I.
K162880TIPCAM 1S 3D System
K162410TIPCAM 1S 3D System
Related Devices (Code: EWY)
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.