510(k) K232970

Hem-o-lok® Ligating Clips by Teleflex Medical — Product Code FZP

K232970 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "Hem-o-lok® Ligating Clips". The FDA issued a decision of Substantially Equivalent on January 12, 2024. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Teleflex Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2024
Date Received
September 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type