KARL STORZ Mediastinoscopes and Instruments
K-Number: K260003 · 2026-03-02
ApplicantKarl Storz SE & CO. KG
Decision Date2026-03-02
Product CodeEWY
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
KARL STORZ Mediastinoscopes and Instruments is a medical device manufactured by Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-03-02 under approval number K260003. 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 KARL STORZ Mediastinoscopes and Instruments?
KARL STORZ Mediastinoscopes and Instruments is a medical device that received FDA 510(k) clearance on 2026-03-02. It is manufactured by Karl Storz SE & CO. KG. The 510(k) number is K260003.
When was KARL STORZ Mediastinoscopes and Instruments approved by the FDA?
KARL STORZ Mediastinoscopes and Instruments received FDA 510(k) clearance on 2026-03-02, under approval number K260003.
What company makes KARL STORZ Mediastinoscopes and Instruments?
KARL STORZ Mediastinoscopes and Instruments is manufactured by Karl Storz SE & CO. KG.
What is the FDA product code for KARL STORZ Mediastinoscopes and Instruments?
The FDA product code for KARL STORZ Mediastinoscopes and Instruments is EWY.
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Official Source
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