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510(k) K143589

GEM Flow COUPLER Device and System by Synovis Life Technologies, Inc. — Product Code MVR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2015
Date Received
December 18, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anastomotic, Microvascular
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances by Synovis Life Technologies, Inc.

  • K223052 — Peri-Guard and Supple Peri-Guard (April 7, 2023)
  • K221032 — Vascu-Guard Vascular Repair Patch (October 19, 2022)
  • K221029 — PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch (October 19, 2022)
  • K142447 — PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (January 7, 2015)
  • K142461 — VASCU-GUARD Peripheral Vascular Patch (November 25, 2014)
  • K142309 — GEM Flow COUPLER Device and System (September 16, 2014)
  • K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM (October 22, 2013)
  • K130896 — VASCULAR PROBE, VASCULAR PROBE ES (April 24, 2013)

Other clearances for product code MVR

  • K190499 — Gem FlowCoupler System (September 6, 2019)
  • K191252 — Gem FlowCoupler System (July 9, 2019)
  • K142309 — GEM Flow COUPLER Device and System (September 16, 2014)
  • K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM (October 22, 2013)
  • K093310 — GEM FLOW COUPLER DEVICE AND SYSTEM (February 1, 2010)
  • K090679 — VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM (April 17, 2009)
  • K040163 — MICROVASCULAR ANASTOMOTIC DEVICE (April 16, 2004)
  • K861985 — 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) (December 4, 1986)