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510(k) K253903

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

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

Other clearances by Taiwan Surgical Corporation

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  • K223593 — Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar (March 22, 2023)
  • K202994 — InnoClip Disposable Clip Applier, InnoClip Clip Applier (January 4, 2022)
  • K150259 — CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L (November 6, 2015)
  • K150253 — Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mm (April 1, 2015)

Other clearances for product code FZP

  • K253781 — InnoClip Clip Applier (December 22, 2025)
  • K250643 — Disposable Polymer Ligation Clips (November 20, 2025)
  • K251054 — Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (July 3, 2025)
  • K242541 — GEM ZIPCLIP (January 15, 2025)
  • K221495 — SOLID CLIP™ Single Use Clip Applier (July 18, 2024)
  • K232970 — Hem-o-lok® Ligating Clips (January 12, 2024)
  • K230966 — angiOCCLUDE Ligating Clips (September 19, 2023)
  • K232313 — LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endo (August 29, 2023)
  • K230480 — Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) (April 28, 2023)
  • K213813 — DuraFuse Clip and Applier System (July 22, 2022)