Coapt Systems, Inc.: FDA clearances and approvals
Coapt Systems, Inc. has 17 FDA 510(k) clearances (first 2002, latest 2009), across 3 product codes in 3 review panels. Median 510(k) review time: 41 days. openFDA lists 1 product recall by a recalling firm named Coapt Systems, 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 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 10 | 10 |
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | 4 | 4 |
| MIX | System, Vocal Cord Medialization | 3 | 3 |
Review panels
Most recent Coapt Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083783 | VF LIQUIGEL | MIX | 2009-09-11 | 266 |
| K080956 | MODIFICATION TO VF GEL PLUS | MIX | 2008-04-25 | 22 |
| K071663 | VF GEL PLUS | MIX | 2008-02-15 | 242 |
| K060249 | ULTRATINE FOREHEAD | HWC | 2006-06-12 | 132 |
| K060248 | ULTRATINE TRANSBLEPH | HWC | 2006-06-12 | 132 |
| K060828 | MODIFICATION TO ENDOTINE RIBBON | GAM | 2006-04-19 | 23 |
| K051415 | ENDOTINE RIBBON | GAM | 2005-06-23 | 22 |
| K050611 | ENDOTINE RIBBON | GAM | 2005-04-06 | 28 |
| K042796 | ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE | HWC | 2004-11-05 | 29 |
| K041835 | ENDOTINE MIDFACE B 4.5 DEVICE | HWC | 2004-09-28 | 83 |
7 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-05-23.
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 Coapt Systems, Inc. have?
Coapt Systems, Inc. has 17 FDA 510(k) clearances (first 2002, latest 2009), across 3 product codes in 3 review panels.
How long does FDA take to clear Coapt Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Coapt Systems, Inc.'s cleared 510(k)s is 41 days.
What devices does Coapt Systems, Inc. make?
Its most frequent FDA product codes are HWC (Screw, Fixation, Bone, 10); GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid, 4); MIX (System, Vocal Cord Medialization, 3).
Has Coapt Systems, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Coapt Systems, Inc; the most recent began 2003-05-23. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 17 Coapt Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Coapt Systems, 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.