Cleared Traditional

KARL STORZ Mediastinoscopes and Instruments

K260003 · Karl Storz SE & CO. KG · Ear, Nose, Throat

Mar 2026

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K260003 is an FDA 510(k) clearance for the KARL STORZ Mediastinoscopes and Instruments, a Mediastinoscope, Surgical (Class II — Special Controls, product code EWY), submitted by Karl Storz SE & CO. KG (Tuttlingen, DE). The FDA issued a Cleared decision on March 2, 2026, 59 days after receiving the submission on January 2, 2026. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4720.

Submission Details

510(k) Number	K260003 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 2026
Decision Date	March 02, 2026
Days to Decision	59 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	EWY — Mediastinoscope, Surgical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4720
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).