DeviceClearance

CLEARVISION Irrigation Sheath 0° (7241AS) +2 more— 510(k) K254299

Substantially Equivalent

Karl Storz SE & CO. KG

FDA 510(k) clearance K254299 for CLEARVISION Irrigation Sheath 0° (7241AS) +2 more, Substantially Equivalent on 2026-09-15. Applicant: Karl Storz SE & CO. KG. Device class: 2.

Summary

Karl Storz SE & CO. KG filed three CLEARVISION Irrigation Sheath versions under product code EOB (Nasopharyngoscope (Flexible Or Rigid)): 0° (7241AS), 30° (7241BS), and 45° (7241FS). The record gives no other detail.

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

Karl Storz filed from Tuttlingen, Germany. The decision came 258 calendar days after FDA received it (December 31, 2025 to September 15, 2026).

Clearance details

Device name as filed
CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)
Applicant
Karl Storz SE & CO. KG
Product code
Product code EOB
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
Tuttlingen, DE
Download summary PDFView on FDA.gov ↗

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Adverse events under product code EOB

product code EOB
Malfunction
6,143
Total
6,143

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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