Confluent Surgical,Inc: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Confluent Surgical,Inc” (first 2004, latest 2009), across 1 product code in 1 review panel. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 6 | 6 |
Review panels
- General Hospital (6)
Most recent Confluent Surgical,Inc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091315 | COVIDIEN EXTENDED TIP APPLICATOR | FMF | 2009-06-05 | 32 |
| K072790 | CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008 | FMF | 2008-01-11 | 102 |
| K070814 | MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP | FMF | 2007-05-30 | 65 |
| K061183 | CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 | FMF | 2006-06-01 | 34 |
| K050998 | CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 | FMF | 2005-06-15 | 56 |
| K042588 | CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 | FMF | 2004-12-09 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Confluent Surgical,Inc.
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 Confluent Surgical,Inc?
FDA lists 6 510(k) clearances under the applicant name “Confluent Surgical,Inc” (first 2004, latest 2009), across 1 product code 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 Confluent Surgical,Inc?
The median time from FDA receipt to decision across 510(k)s cleared under the name Confluent Surgical,Inc is 60 days.
Which FDA product codes appear under Confluent Surgical,Inc?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 6).
Next steps
- See all 6 Confluent Surgical,Inc clearances with predicates and recalls
- Run predicate analysis for product code FMF, Confluent Surgical,Inc'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.