Cox-Uphuff Intl.: FDA clearances and approvals
Cox-Uphuff Intl. has 11 FDA 510(k) clearances (first 1980, latest 1987), across 10 product codes in 3 review panels. Median 510(k) review time: 24 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 |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | 2 | 2 |
| FTY | Tape, Measuring, Rulers And Calipers | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| FZW | Expander, Surgical, Skin Graft | 1 | 1 |
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| GEJ | Carrier, Ligature | 1 | 1 |
| LFB | Button, Nasal Septal | 1 | 1 |
| MRD | Mammary Sizer | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Cox-Uphuff Intl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874276 | CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER | FZW | 1987-12-02 | 43 |
| K874342 | LIGATURE CARRIER/PACKER, HYDROXYLAPATITE | GEJ | 1987-11-13 | 24 |
| K873470 | TEMPLATE | FTY | 1987-09-08 | 11 |
| K865056 | CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER | LCJ | 1987-05-22 | 149 |
| K871200 | CUI NASAL SEPTUM BUTTON | LFB | 1987-04-15 | 21 |
| K865033 | BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER | LCJ | 1987-01-12 | 20 |
| K854339 | CUI CHIN SIZER | — | 1985-11-15 | 18 |
| K853945 | CUI RHINOPLASTY IMPLANTS | FZE | 1985-10-18 | 24 |
| K831566 | CUI MAMMARY PROTHESIS SIZER | MRD | 1983-08-12 | 88 |
| K813394 | DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM | GCX | 1982-01-22 | 49 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cox-Uphuff Intl..
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 Cox-Uphuff Intl. have?
Cox-Uphuff Intl. has 11 FDA 510(k) clearances (first 1980, latest 1987), across 10 product codes in 3 review panels.
How long does FDA take to clear Cox-Uphuff Intl.'s 510(k)s?
The median time from FDA receipt to decision across Cox-Uphuff Intl.'s cleared 510(k)s is 24 days.
What devices does Cox-Uphuff Intl. make?
Its most frequent FDA product codes are LCJ (Tissue Expander And Accessories, 2); FTY (Tape, Measuring, Rulers And Calipers, 1); FZE (Prosthesis, Nose, Internal, 1).
Has Cox-Uphuff Intl. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cox-Uphuff Intl. Related entities may recall under other names.
Next steps
- See all 11 Cox-Uphuff Intl. clearances with predicates and recalls
- Run predicate analysis for product code LCJ, Cox-Uphuff Intl.'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.