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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applier, Aneurysm Clip
510(k) Number K211572
Device Name Aesculap Slim Clip Applier
Applicant
Aesculap, Inc
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact Paul Amudala
Correspondent
Aesculap, Inc
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact Paul Amudala
Regulation Number882.4175
Classification Product Code
HCI  
Date Received05/21/2021
Decision Date 12/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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