Synovis Micro Companies Alliance, Inc.: FDA clearances and approvals
Synovis Micro Companies Alliance, Inc. has 5 FDA 510(k) clearances (first 2004, latest 2024), across 4 product codes in 3 review panels. Median 510(k) review time: 102 days. Since 2017 its median was 117 days, against 101 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Synovis Micro Companies Alliance, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 102 |
| 2023 | 0 | — |
| 2024 | 1 | 117 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Synovis Micro Companies Alliance, Inc.'s cleared 510(k)s took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MVR | Device, Anastomotic, Microvascular | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 1 | 1 |
Review panels
Most recent Synovis Micro Companies Alliance, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233394 | Gem Flow Now (GEM2770-FN) | IYN | 2024-01-28 | 117 |
| K221843 | GEM Biover Microvascular Clamps | DXC | 2022-09-14 | 82 |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2) | DPW | 2022-04-20 | 121 |
| K093310 | GEM FLOW COUPLER DEVICE AND SYSTEM | MVR | 2010-02-01 | 102 |
| K040163 | MICROVASCULAR ANASTOMOTIC DEVICE | MVR | 2004-04-16 | 81 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-05-14.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Synovis Micro Companies Alliance, Inc. have?
Synovis Micro Companies Alliance, Inc. has 5 FDA 510(k) clearances (first 2004, latest 2024), across 4 product codes in 3 review panels.
How long does FDA take to clear Synovis Micro Companies Alliance, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Synovis Micro Companies Alliance, Inc.'s cleared 510(k)s is 102 days. Since 2017: 117 days, versus 101 days for all cleared 510(k)s in the same product codes.
What devices does Synovis Micro Companies Alliance, Inc. make?
Its most frequent FDA product codes are MVR (Device, Anastomotic, Microvascular, 2); DPW (Flowmeter, Blood, Cardiovascular, 1); DXC (Clamp, Vascular, 1).
Has Synovis Micro Companies Alliance, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Synovis Micro Companies Alliance, Inc; the most recent began 2008-05-14. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 5 Synovis Micro Companies Alliance, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MVR, Synovis Micro Companies Alliance, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.