510(k) K180914

Aesculap Slim Clip Applier by Aesculap, Inc. — Product Code HCI

K180914 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "Aesculap Slim Clip Applier". The FDA issued a decision of Substantially Equivalent on April 17, 2018. The device falls under product code HCI (Applier, Aneurysm Clip), a Class II device regulated under 21 CFR 882.4175. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2018
Date Received
April 9, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applier, Aneurysm Clip
Device Class
Class II
Regulation Number
882.4175
Review Panel
NE
Submission Type