510(k) K202994

InnoClip Disposable Clip Applier, InnoClip Clip Applier by Taiwan Surgical Corporation — Product Code FZP

K202994 is an FDA 510(k) premarket notification submitted by Taiwan Surgical Corporation for the device "InnoClip Disposable Clip Applier, InnoClip Clip Applier". The FDA issued a decision of Substantially Equivalent on January 4, 2022. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Taiwan Surgical Corporation has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2022
Date Received
October 1, 2020
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