KARL STORZ Laryngoscopes and Accessories— 510(k) K252624

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K252624 for KARL STORZ Laryngoscopes and Accessories, Substantially Equivalent on 2026-05-15. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.

Summary

KARL STORZ Endoscopy-America filed KARL STORZ Laryngoscopes and Accessories under EQN, laryngoscopes and nasopharyngoscopes. The device name is generic.

Class II, 21 CFR 874.4760. Ear, Nose, Throat is both the classification panel and the review panel, and the submission was a Traditional 510(k).

KARL STORZ filed from El Segundo, California. Review took 270 calendar days (August 18, 2025 to May 15, 2026).

Clearance details

Applicant
KARL STORZ Endoscopy-America, Inc.
Product code
Product code EQN
Device class
Class 2
Regulation
21 CFR 874.4760
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
El Segundo, CA, US
Download summary PDFView on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.