510(k) K131500

YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS by Aesculap, Inc. — Product Code HCH

K131500 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS". The FDA issued a decision of Substantially Equivalent on January 24, 2014. The device falls under product code HCH (Clip, Aneurysm), a Class II device regulated under 21 CFR 882.5200. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2014
Date Received
May 24, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Aneurysm
Device Class
Class II
Regulation Number
882.5200
Review Panel
NE
Submission Type