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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name esophagoscope (flexible or rigid)
510(k) Number K142695
Device Name Cytosponge Cell Collection Device
Applicant
Covidien LLC
15 HAMPSHIRE ST
mansfield,  MA  02048
Applicant Contact richelle hover
Correspondent
Covidien LLC
15 HAMPSHIRE ST
mansfield,  MA  02048
Correspondent Contact richelle hover
Regulation Number874.4710
Classification Product Code
EOX  
Date Received09/22/2014
Decision Date 11/26/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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