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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-03-02 under 510(k) 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. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K260003.

When did KARL STORZ Mediastinoscopes and Instruments receive FDA 510(k) clearance?

KARL STORZ Mediastinoscopes and Instruments received FDA 510(k) clearance on 2026-03-02, under 510(k) number K260003.

Who is the listed applicant for KARL STORZ Mediastinoscopes and Instruments?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KARL STORZ Mediastinoscopes and Instruments?

The FDA product code for KARL STORZ Mediastinoscopes and Instruments is EWY.

Other records listing Karl Storz SE & CO. KG 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.

K261706Endomat Select (UP220)K252800KARL STORZ Endoscopic Accessories for UrologyK254228KARL STORZ Trocars with Valve SealsK254242KARL STORZ ICG Imaging System with RUBINA® LensK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)K251731KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612)

View all 26 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.

K213194HD MediastinoscopeKarl Storz Endoscopy America, Inc.K202272HD 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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