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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

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

FDA 510(k) source

510(k) number
K254299
Applicant
Karl Storz SE & CO. KG
Decision date
Sep 15, 2026
Date received
Dec 31, 2025
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
EOB
Device type
Nasopharyngoscope (Flexible Or Rigid)
Device class
Class II
Regulation
21 CFR 874.4760
Advisory committee
Ear, Nose, Throat
Third party
N
Location
Tuttlingen, DE