510(k) K191252
- Device
- Gem FlowCoupler System
- Applicant
- Baxter/ Synovis Micro Companies Alliance Inc.
- 510(k) number
- K191252
- Product code
- MVR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-09
- Date received
- 2019-05-09
- Regulation
- 878.4300
- Classification name
- Device, Anastomotic, Microvascular
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Julie Carlston
- Address
- 2875 University Ave. W. St. Paul MN US 55114 55114
FDA Registration Numbers#
- 2183744
- 2183967
- 1416980
- 1062741
Source Documents#
Other 510(k) Records For Product Code MVR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K190499 | Gem FlowCoupler System | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-09-06 |
| 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 |
Legacy Summary#
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FDA Review#
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