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Parker Quality & Compliance

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510(k) clearance

KARL STORZ Flexible Video Neuro-Endoscope

FDA 510(k) source

510(k) number
K260581
Applicant
Karl Storz SE & CO. KG
Decision date
Oct 14, 2026
Date received
Feb 20, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
GWG
Device type
Endoscope, Neurological
Device class
Class II
Regulation
21 CFR 882.1480
Advisory committee
Neurology
Statement or summary
Summary
Third party
N
Location
Tuttlingen, DE