Gem FlowCoupler System
FDA 510(k) clearance K191252 · decided 2019-07-09
Clearance details
- K-number
- K191252
- Device name
- Gem FlowCoupler System
- Applicant
- Baxter/ Synovis Micro Companies Alliance, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-09
- Decision date
- 2019-07-09
- Days to decision
- 61 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
- St. Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Gem FlowCoupler System (K190499) | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-09-06 |
| 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 |
| MICROVASCULAR ANASTOMOTIC DEVICE (K040163) | Synovis Micro Companies Alliance, Inc. | 2004-04-16 |
| 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) (K861985) | 3M Company | 1986-12-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GEM FLOW COUPLER Monitor, PN 5156-00000-011 recall (Z-2208-2023) | Baxter Healthcare Corporation | 2023-07-20 |