Eagle Twe, Inc.: FDA clearances and approvals
Eagle Twe, Inc. has 5 FDA 510(k) clearances (first 2001, latest 2005), across 1 product code in 1 review panel. Median 510(k) review time: 90 days.
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 |
|---|---|---|---|
| HIS | Condom | 5 | 5 |
Review panels
Most recent Eagle Twe, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051273 | DIVAS DUAL PLEASURE MALE LATEX CONDOM | HIS | 2005-08-19 | 94 |
| K010028 | SHEER THIN AROMAS RED LATEX CONDOM | HIS | 2001-03-30 | 86 |
| K004051 | SHEER THIN AROMAS YELLOW LATEX CONDOM | HIS | 2001-03-29 | 90 |
| K004036 | SHEER THIN AROMAS GREEN LATEX CONDOM | HIS | 2001-03-27 | 89 |
| K004016 | SHEER THIN AROMAS BLUE LATEX CONDOM | HIS | 2001-03-27 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Eagle Twe, 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 Eagle Twe, Inc. have?
Eagle Twe, Inc. has 5 FDA 510(k) clearances (first 2001, latest 2005), across 1 product code in 1 review panel.
How long does FDA take to clear Eagle Twe, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Eagle Twe, Inc.'s cleared 510(k)s is 90 days.
What devices does Eagle Twe, Inc. make?
Its most frequent FDA product codes are HIS (Condom, 5).
Has Eagle Twe, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Eagle Twe, Inc. Related entities may recall under other names.
Next steps
- See all 5 Eagle Twe, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Eagle Twe, 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.