FDA 510(k) clearance · back to tracker

KARL STORZ Flexible Video Neuro-Endoscope

Karl Storz SE & CO. KG cleared K260581 on 2026-10-14, decision: substantially equivalent

K-number

K260581

Sponsor

Karl Storz SE & CO. KG

Device

KARL STORZ Flexible Video Neuro-Endoscope

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-14

Product code

GWG

Advisory committee

Neurology

Medical specialty

Neurology

Regulation number

882.1480

Official FDA record

Open K260581on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.