Dixon Medical, Inc.: FDA clearances and approvals
Dixon Medical, Inc. has 12 FDA 510(k) clearances (first 1990, latest 1990), across 1 product code in 1 review panel. Median 510(k) review time: 35 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 12 | 12 |
Review panels
Most recent Dixon Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903600 | ESPI MICRO GRASPER,DOUBLE-ACTION,INSULATED,#8250-N | HET | 1990-10-17 | 70 |
| K903599 | ESPI DOUBLE-ACTION INSULATED GRASPER, #8203-N | HET | 1990-10-17 | 70 |
| K903598 | ESPI DOUBLE-ACTION GRASPER, INSULATED, #8202-N | HET | 1990-10-17 | 70 |
| K903602 | ESPI NON-INSULATED DOUBLE-ACTION GRASPER, #8203 | HET | 1990-09-12 | 35 |
| K903601 | ESPI NON-INSULATED DOUBLE-ACTION GRASPER #8204 | HET | 1990-09-12 | 35 |
| K903597 | ESPI MICRO SCISSORS, #8150 | HET | 1990-09-12 | 35 |
| K903596 | ESPI REDUCER SLEEVE, #8415 | HET | 1990-09-12 | 35 |
| K903595 | ESPI CLAW FORCEP, #8302, 10MM, 30CM | HET | 1990-09-12 | 35 |
| K903594 | ESPI TISSUE GRASPER/NEEDLE HOLDER, #8201 | HET | 1990-09-12 | 35 |
| K903593 | ESPI APPLICATOR SLEEVE, #8410 | HET | 1990-09-12 | 35 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dixon Medical, 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 Dixon Medical, Inc. have?
Dixon Medical, Inc. has 12 FDA 510(k) clearances (first 1990, latest 1990), across 1 product code in 1 review panel.
How long does FDA take to clear Dixon Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dixon Medical, Inc.'s cleared 510(k)s is 35 days.
What devices does Dixon Medical, Inc. make?
Its most frequent FDA product codes are HET (Laparoscope, Gynecologic (And Accessories), 12).
Has Dixon Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dixon Medical, Inc. Related entities may recall under other names.
Next steps
- See all 12 Dixon Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HET, Dixon Medical, 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.