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510(k) K191252

Gem FlowCoupler System by Baxter/ Synovis Micro Companies Alliance, Inc. — Product Code MVR

K191252 is an FDA 510(k) premarket notification submitted by Baxter/ Synovis Micro Companies Alliance, Inc. for the device "Gem FlowCoupler System". The FDA issued a decision of Substantially Equivalent on July 9, 2019. The device falls under product code MVR (Device, Anastomotic, Microvascular), a Class II device regulated under 21 CFR 878.4300. Baxter/ Synovis Micro Companies Alliance, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2019
Date Received
May 9, 2019
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 Baxter/ Synovis Micro Companies Alliance, Inc.

  • K190499 — Gem FlowCoupler System (September 6, 2019)

Other clearances for product code MVR

  • K190499 — Gem FlowCoupler System (September 6, 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)
  • 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)

FDA data resources