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510(k) K032980

AMI REPROCESSED MULTIPLE CLIP APPLIERS by Vanguard Medical Concepts, Inc. — Product Code FZP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2003
Date Received
September 24, 2003
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 Vanguard Medical Concepts, Inc.

  • K053051 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (December 22, 2005)
  • K051616 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (September 6, 2005)
  • K051180 — VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (July 22, 2005)
  • K051043 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (June 6, 2005)
  • K050763 — VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS (June 1, 2005)
  • K043198 — VANGUARD REPROCESSED ARTHROSCOPIC WANDS (May 27, 2005)
  • K043253 — VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS (April 8, 2005)
  • K043594 — VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES (March 31, 2005)
  • K043225 — VANGUARD REPROCESSED ULTRASONIC SCALPEL (March 22, 2005)
  • K043315 — VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL (March 22, 2005)

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)