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510(k) K251054

Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips by Teleflex Medical — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
April 4, 2025
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

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Other clearances for product code FZP

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  • 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)