Synovis Life Technologies, Inc.: FDA clearances and approvals
Synovis Life Technologies, Inc. has 9 FDA 510(k) clearances (first 2013, latest 2023), across 5 product codes in 2 review panels. Median 510(k) review time: 84 days. Since 2017 its median was 195 days, against 146 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 2 | 36 |
| 2014 | 2 | 56 |
| 2015 | 2 | 78 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 195 |
| 2023 | 1 | 190 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Synovis Life Technologies, Inc.'s cleared 510(k)s took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MVR | Device, Anastomotic, Microvascular | 3 | 3 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | 2 | 2 |
| DWP | Dilator, Vessel, Surgical | 1 | 1 |
| FTM | Mesh, Surgical | 1 | 1 |
Review panels
Most recent Synovis Life Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223052 | Peri-Guard and Supple Peri-Guard | FTM | 2023-04-07 | 190 |
| K221032 | Vascu-Guard Vascular Repair Patch | PSQ | 2022-10-19 | 195 |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | PSQ | 2022-10-19 | 195 |
| K143589 | GEM Flow COUPLER Device and System | MVR | 2015-01-16 | 29 |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | DXZ | 2015-01-07 | 127 |
| K142461 | VASCU-GUARD Peripheral Vascular Patch | DXZ | 2014-11-25 | 84 |
| K142309 | GEM Flow COUPLER Device and System | MVR | 2014-09-16 | 28 |
| K132727 | GEM FLOW COUPLER DEVICE AND SYSTEM | MVR | 2013-10-22 | 49 |
| K130896 | VASCULAR PROBE, VASCULAR PROBE ES | DWP | 2013-04-24 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Synovis Life Technologies, Inc..
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 Life Technologies, Inc. have?
Synovis Life Technologies, Inc. has 9 FDA 510(k) clearances (first 2013, latest 2023), across 5 product codes in 2 review panels.
How long does FDA take to clear Synovis Life Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Synovis Life Technologies, Inc.'s cleared 510(k)s is 84 days. Since 2017: 195 days, versus 146 days for all cleared 510(k)s in the same product codes.
What devices does Synovis Life Technologies, Inc. make?
Its most frequent FDA product codes are MVR (Device, Anastomotic, Microvascular, 3); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 2); PSQ (Intracardiac Patch Or Pledget, Biologically Derived, 2).
Has Synovis Life Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Synovis Life Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 9 Synovis Life Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MVR, Synovis Life Technologies, 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.