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510(k) K093310

GEM FLOW COUPLER DEVICE AND SYSTEM by Synovis Micro Companies Alliance, Inc. — Product Code MVR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2010
Date Received
October 22, 2009
Clearance Type
Traditional
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 Micro Companies Alliance, Inc.

  • K233394 — Gem Flow Now (GEM2770-FN) (January 28, 2024)
  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)
  • K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2) (April 20, 2022)
  • K040163 — MICROVASCULAR ANASTOMOTIC DEVICE (April 16, 2004)

Other clearances for product code MVR

  • K190499 — Gem FlowCoupler System (September 6, 2019)
  • K191252 — Gem FlowCoupler System (July 9, 2019)
  • K143589 — GEM Flow COUPLER Device and System (January 16, 2015)
  • K142309 — GEM Flow COUPLER Device and System (September 16, 2014)
  • K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM (October 22, 2013)
  • 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)