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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K233524
Device Name Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)
Applicant
Hollister Incorporated
2000 Hollister Drive
Libertyville,  IL  60048
Applicant Contact Michelle Schiltz-Taing
Correspondent
Hollister Incorporated
2000 Hollister Drive
Libertyville,  IL  60048
Correspondent Contact Michelle Schiltz-Taing
Regulation Number876.5130
Classification Product Code
EZD  
Date Received11/01/2023
Decision Date 05/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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