Orbus Medical Technologies: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Orbus Medical Technologies” (first 2001, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time under this name: 82 days. 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 8 | 8 |
Review panels
Most recent Orbus Medical Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041370 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS | FGE | 2004-06-24 | 31 |
| K041032 | MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS | FGE | 2004-05-10 | 19 |
| K040550 | LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS | FGE | 2004-03-16 | 14 |
| K033212 | LIFESTENT SDS BILIARY ENDOPROSTHESIS | FGE | 2003-10-30 | 27 |
| K023308 | LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS | FGE | 2003-04-14 | 193 |
| K023121 | LIFESTENT BILIARY ENDOPROSTHESIS | FGE | 2003-03-10 | 172 |
| K023248 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS | FGE | 2003-02-11 | 134 |
| K010107 | R STENT BILIARY ENDOPROSTHESIS | FGE | 2001-07-31 | 200 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-03-19.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Orbus Medical Technologies?
FDA lists 8 510(k) clearances under the applicant name “Orbus Medical Technologies” (first 2001, latest 2004), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Orbus Medical Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orbus Medical Technologies is 82 days.
Which FDA product codes appear under Orbus Medical Technologies?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 8).
Next steps
- See all 8 Orbus Medical Technologies clearances with predicates and recalls
- Run predicate analysis for product code FGE, Orbus Medical Technologies'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.