Home / 510(k) Clearances / K003958

510(k) K003958

COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE by Coalescent Surgical — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2001
Date Received
December 21, 2000
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

Other clearances by Coalescent Surgical

  • K040821 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES (April 23, 2004)
  • K031623 — MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES (July 3, 2003)
  • K024366 — COALESCENT SURGICAL U-CLIP AND ACCESSORIES (January 17, 2003)
  • K023125 — COALESCENT U-CLIP- AND ACCESSORIES (December 18, 2002)
  • K021407 — COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES (July 3, 2002)
  • K013664 — COALESCENT SURGICAL U-CLIP (January 24, 2002)
  • K012317 — COALESCENT SURGICAL U-CLIP (August 31, 2001)
  • K994160 — COALESCENT SURGICAL SUTURED-CLIP (February 4, 2000)

Other clearances for product code FZP

  • K253781 — InnoClip Clip Applier (December 22, 2025)
  • K253903 — InnoClip Disposable 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)