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The Tracker / September 2026 / K254299

510(k) cleared

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

Karl Storz SE & CO. KG · Sep 15, 2026 · K254299

FDA cleared the CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) from Karl Storz SE & CO. KG on Sep 15, 2026 under K254299, a traditional 510(k). The device falls under product code EOB, Nasopharyngoscope (Flexible Or Rigid), regulated at 21 CFR 874.4760 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Dec 31, 2025. The decision came 258 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Karl Storz SE & CO. KG has 8 other decisions in the tracker over the last 12 months: K254252 (UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10)), K254303 (KARL STORZ SUPRALOOP), K261102 (UNIDRIVE Select System), K260884 (UNIDRIVE Select System).

Questions & Answers

What did FDA clear under K254299?

K254299 is the FDA 510(k) for CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS), submitted by Karl Storz SE & CO. KG. FDA's decision date was Sep 15, 2026, under product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

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

Karl Storz SE & CO. KG, based in Tuttlingen, is the applicant of record for K254299.

How long did the K254299 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Sep 15, 2026, 258 days later.

← All decisions in September 2026