Product code MVR

Device name: Device, Anastomotic, Microvascular
Medical specialty: General, Plastic Surgery
Device class: 2
Regulation number: 878.4300
Review panel: SU
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K190499	Gem FlowCoupler System	Baxter/ Synovis Micro Companies Alliance, Inc.	2019-09-06
K191252	Gem FlowCoupler System	Baxter/ Synovis Micro Companies Alliance, Inc.	2019-07-09
K143589	GEM Flow COUPLER Device and System	Synovis Life Technologies, Inc.	2015-01-16
K142309	GEM Flow COUPLER Device and System	Synovis Life Technologies, Inc.	2014-09-16
K132727	GEM FLOW COUPLER DEVICE AND SYSTEM	Synovis Life Technologies, Inc.	2013-10-22
K093310	GEM FLOW COUPLER DEVICE AND SYSTEM	Synovis Micro Companies Alliance, Inc.	2010-02-01
K090679	VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM	Vioptix, Inc.	2009-04-17
K040163	MICROVASCULAR ANASTOMOTIC DEVICE	Synovis Micro Companies Alliance, Inc.	2004-04-16
K861985	3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)	3M Company	1986-12-04

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00844735006179	GEM VESSEL EVERTER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2019-10-30
10844735006176	GEM VESSEL EVERTER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2019-10-30
10844735002604	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735006018	GEM FLOW COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
10844735002727	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002713	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
10844735002703	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002690	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
10844735002680	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002676	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
10844735002666	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002652	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
10844735002642	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002638	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
10844735002628	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002614	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002607	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002591	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735006032	GEM FLOW COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735006025	GEM FLOW COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735006001	GEM FLOW COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735005998	GEM FLOW COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002720	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002706	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002683	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002669	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002645	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08
00844735002621	GEM Microvascular Anastomotic COUPLER	SYNOVIS MICRO COMPANIES ALLIANCE, INC	2015-10-08

Product code MVR

Related 510(k) Records#

Related GUDID Devices#