Corinth Medtech, Inc.: FDA clearances and approvals
Corinth Medtech, Inc. has 7 FDA 510(k) clearances (first 2017, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time: 52 days. Since 2017 its median was 52 days, against 132 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 149 |
| 2018 | 1 | 125 |
| 2019 | 4 | 38 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 30 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Corinth Medtech, Inc.'s cleared 510(k)s took a median 52 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FJL | Resectoscope | 4 | 4 |
| HIH | Hysteroscope (And Accessories) | 3 | 3 |
Review panels
Most recent Corinth Medtech, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230205 | Veloxion System | FJL | 2023-02-24 | 30 |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | FJL | 2019-06-13 | 24 |
| K191335 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | HIH | 2019-06-06 | 20 |
| K190113 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | HIH | 2019-04-24 | 90 |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch | FJL | 2019-03-15 | 52 |
| K180752 | Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole | HIH | 2018-07-25 | 125 |
| K162979 | Veloxion System | FJL | 2017-03-24 | 149 |
Recalls
openFDA lists no recalls under a recalling firm named Corinth Medtech, 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 Corinth Medtech, Inc. have?
Corinth Medtech, Inc. has 7 FDA 510(k) clearances (first 2017, latest 2023), across 2 product codes in 2 review panels.
How long does FDA take to clear Corinth Medtech, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Corinth Medtech, Inc.'s cleared 510(k)s is 52 days. Since 2017: 52 days, versus 132 days for all cleared 510(k)s in the same product codes.
What devices does Corinth Medtech, Inc. make?
Its most frequent FDA product codes are FJL (Resectoscope, 4); HIH (Hysteroscope (And Accessories), 3).
Has Corinth Medtech, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Corinth Medtech, Inc. Related entities may recall under other names.
Next steps
- See all 7 Corinth Medtech, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FJL, Corinth Medtech, 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.