510(k) K253903

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

K253903 is an FDA 510(k) premarket notification submitted by Taiwan Surgical Corporation for the device "InnoClip Disposable Clip Applier". The FDA issued a decision of Substantially Equivalent on December 22, 2025. 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
December 22, 2025
Date Received
December 5, 2025
Clearance Type
Special
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