Home / 510(k) Clearances / K213974

510(k) K213974

GEM FLOW COUPLER Monitor (GEM1020M-2) by Synovis Micro Companies Alliance, Inc. — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2022
Date Received
December 20, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
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)
  • K093310 — GEM FLOW COUPLER DEVICE AND SYSTEM (February 1, 2010)
  • K040163 — MICROVASCULAR ANASTOMOTIC DEVICE (April 16, 2004)

Other clearances for product code DPW

  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K251114 — FloPatch FP120 (June 20, 2025)
  • K243852 — Elfor-L (April 14, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K223843 — FloPatch FP120 (May 3, 2023)
  • K222242 — FloPatch FP120 (December 9, 2022)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
  • K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
  • K201114 — Bidop 7 (January 5, 2021)
  • K200337 — FloPatch (FP120) (March 24, 2020)