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FDA 510(k)

CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)

K-Number: K254299 · 2026-09-15

ApplicantKarl Storz SE & CO. KG
Decision Date2026-09-15
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz SE & CO. KG. It received FDA 510(k) clearance on 2026-09-15 under 510(k) number K254299. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)?

CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) is a medical device that received FDA 510(k) clearance on 2026-09-15. The listed applicant is Karl Storz SE & CO. KG. The 510(k) number is K254299.

When did CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) receive FDA 510(k) clearance?

CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) received FDA 510(k) clearance on 2026-09-15, under 510(k) number K254299.

Who is the listed applicant for CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)?

The FDA 510(k) record lists Karl Storz SE & CO. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS)?

The FDA product code for CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) is EOB.

Other records listing Karl Storz SE & CO. KG as applicant

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Related Devices (Code: EOB)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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