Coalescent Surgical: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Coalescent Surgical” (first 2000, latest 2004), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 47 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FZP | Clip, Implantable | 7 | 7 |
| NCA | Clip, Implantable, For Coronary Artery Bypass Graft (Cabg) | 1 | 1 |
| NJU | Suture, Nonabsorbable, Nitinol | 1 | 1 |
Review panels
Most recent Coalescent Surgical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040821 | COALESCENT SURGICAL U-CLIP AND ACCESSORIES | FZP | 2004-04-23 | 24 |
| K031623 | MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES | FZP | 2003-07-03 | 41 |
| K024366 | COALESCENT SURGICAL U-CLIP AND ACCESSORIES | FZP | 2003-01-17 | 17 |
| K023125 | COALESCENT U-CLIP- AND ACCESSORIES | NJU | 2002-12-18 | 90 |
| K021407 | COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES | FZP | 2002-07-03 | 61 |
| K013664 | COALESCENT SURGICAL U-CLIP | NCA | 2002-01-24 | 79 |
| K012317 | COALESCENT SURGICAL U-CLIP | FZP | 2001-08-31 | 39 |
| K003958 | COALESCENT U-CLIP DELIVERY AND DISPOSAL DEVICE | FZP | 2001-02-06 | 47 |
| K994160 | COALESCENT SURGICAL SUTURED-CLIP | FZP | 2000-02-04 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Coalescent Surgical.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Coalescent Surgical?
FDA lists 9 510(k) clearances under the applicant name “Coalescent Surgical” (first 2000, latest 2004), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Coalescent Surgical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coalescent Surgical is 47 days.
Which FDA product codes appear under Coalescent Surgical?
The most frequent FDA product codes under this applicant name are FZP (Clip, Implantable, 7); NCA (Clip, Implantable, For Coronary Artery Bypass Graft (Cabg), 1); NJU (Suture, Nonabsorbable, Nitinol, 1).
Next steps
- See all 9 Coalescent Surgical clearances with predicates and recalls
- Run predicate analysis for product code FZP, Coalescent Surgical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.