Gem FlowCoupler System— 510(k) K190499

Name: FDA 510(k) clearance K190499
Creator: U.S. Food and Drug Administration
Published: 2019-09-06

Substantially Equivalent

Baxter/ Synovis Micro Companies Alliance, Inc.

FDA 510(k) clearance K190499 for Gem FlowCoupler System, Substantially Equivalent on 2019-09-06. Applicant: Baxter/ Synovis Micro Companies Alliance, Inc.. Device class: 2.

Clearance details

Applicant: Baxter/ Synovis Micro Companies Alliance, Inc.
Product code: Code MVR
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 2019-03-01
Decision date: 2019-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MVR

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K191252 — Gem FlowCoupler System2019-07-09
K143589 — GEM Flow COUPLER Device and System2015-01-16
K142309 — GEM Flow COUPLER Device and System2014-09-16
K132727 — GEM FLOW COUPLER DEVICE AND SYSTEM2013-10-22
K093310 — GEM FLOW COUPLER DEVICE AND SYSTEM2010-02-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.