Cox Medical Ent., Inc.: FDA clearances and approvals
Cox Medical Ent., Inc. has 15 FDA 510(k) clearances (first 1991, latest 1995), across 7 product codes in 2 review panels. Median 510(k) review time: 70 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 |
|---|---|---|---|
| FCL | Forceps, Biopsy, Non-Electric | 3 | 3 |
| FEB | Accessories, Cleaning, For Endoscope | 3 | 3 |
| FDI | Snare, Flexible | 2 | 2 |
| FDX | Endoscopic Cytology Brush | 2 | 2 |
| KGE | Forceps, Biopsy, Electric | 2 | 2 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 2 | 2 |
| MNL | Accessories, Cleaning Brushes, For Endoscope | 1 | 1 |
Review panels
Most recent Cox Medical Ent., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950689 | UCB | MNL | 1995-03-06 | 20 |
| K946360 | MODULAR BIOPSY FORCEP | FCL | 1995-03-06 | 66 |
| K941464 | BASICS ENDOSCOPY SYSTEM | OCZ | 1994-08-05 | 130 |
| K940911 | BASICS ENDOSCOPY SYSTEM | KGE | 1994-05-16 | 80 |
| K932790 | THERMAL OPTION | KGE | 1994-01-28 | 233 |
| K935250 | ACCU-PATH | FCL | 1994-01-21 | 81 |
| K924655 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2) | FEB | 1992-12-15 | 91 |
| K923671 | COX DISPOSABLE POLYPECTOMY SNARES | FDI | 1992-10-13 | 83 |
| K923672 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH | FEB | 1992-09-23 | 63 |
| K923489 | COX DISPOSABLE RETRIEVAL DEVICES | OCZ | 1992-09-23 | 70 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cox Medical Ent., 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 Cox Medical Ent., Inc. have?
Cox Medical Ent., Inc. has 15 FDA 510(k) clearances (first 1991, latest 1995), across 7 product codes in 2 review panels.
How long does FDA take to clear Cox Medical Ent., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cox Medical Ent., Inc.'s cleared 510(k)s is 70 days.
What devices does Cox Medical Ent., Inc. make?
Its most frequent FDA product codes are FCL (Forceps, Biopsy, Non-Electric, 3); FEB (Accessories, Cleaning, For Endoscope, 3); FDI (Snare, Flexible, 2).
Has Cox Medical Ent., Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cox Medical Ent., Inc. Related entities may recall under other names.
Next steps
- See all 15 Cox Medical Ent., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FCL, Cox Medical Ent., 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.