MICROVASCULAR ANASTOMOTIC DEVICE
FDA 510(k) clearance K040163 · decided 2004-04-16
Clearance details
- K-number
- K040163
- Device name
- MICROVASCULAR ANASTOMOTIC DEVICE
- Applicant
- Synovis Micro Companies Alliance, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-26
- Decision date
- 2004-04-16
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- MVR
- Device class
- 2
- Regulation number
- 878.4300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Birmingham, AL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Gem FlowCoupler System (K190499) | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-09-06 |
| Gem FlowCoupler System (K191252) | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-07-09 |
| GEM Flow COUPLER Device and System (K143589) | Synovis Life Technologies, Inc. | 2015-01-16 |
| GEM Flow COUPLER Device and System (K142309) | Synovis Life Technologies, Inc. | 2014-09-16 |
| GEM FLOW COUPLER DEVICE AND SYSTEM (K132727) | Synovis Life Technologies, Inc. | 2013-10-22 |
| GEM FLOW COUPLER DEVICE AND SYSTEM (K093310) | Synovis Micro Companies Alliance, Inc. | 2010-02-01 |
| VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM (K090679) | Vioptix, Inc. | 2009-04-17 |
| 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) (K861985) | 3M Company | 1986-12-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx recall (Z-2138-2008) | Synovis Micro Companies Alliance Inc | 2008-08-02 |