Medeon Biodesign, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medeon Biodesign, Inc.” (first 2015, latest 2020), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 85 days. Since 2017 the median was 32 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 115 |
| 2016 | 2 | 160 |
| 2017 | 1 | 35 |
| 2018 | 0 | — |
| 2019 | 1 | 28 |
| 2020 | 2 | 57 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medeon Biodesign, Inc. took a median 32 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 5 | 5 |
| OCW | Endoscopic Tissue Approximation Device | 2 | 2 |
Review panels
Most recent Medeon Biodesign, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200902 | ClickClean | GCJ | 2020-04-30 | 27 |
| K193652 | AbClose - Port Site Closure Device | OCW | 2020-03-26 | 87 |
| K192891 | Laparoscope Lens Shield Device (LENS) | GCJ | 2019-11-07 | 28 |
| K170103 | Laparoscope Lens Shield Device (LENS) | GCJ | 2017-02-16 | 35 |
| K160117 | AbClose - Port Site Closure Device | OCW | 2016-09-09 | 234 |
| K160172 | Laparoscope Lens Shield Device | GCJ | 2016-04-21 | 85 |
| K151117 | Laparoscope Lens Shield Device | GCJ | 2015-08-20 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Medeon Biodesign, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Medeon Biodesign, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03171155: Clinical Study of the Medeon Biodesign XPro™ (Completed, started 2017-05-25)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medeon Biodesign, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Medeon Biodesign, Inc.” (first 2015, latest 2020), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medeon Biodesign, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medeon Biodesign, Inc. is 85 days. Since 2017: 32 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medeon Biodesign, Inc.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 5); OCW (Endoscopic Tissue Approximation Device, 2).
Next steps
- See all 7 Medeon Biodesign, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Medeon Biodesign, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.