Ellipse A/S: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ellipse A/S” (first 2007, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 144 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 | 1 | 191 |
| 2015 | 1 | 95 |
| 2016 | 1 | 144 |
| 2017 | 0 | — |
| 2018 | 1 | 29 |
| 2019 | 0 | — |
| 2020 | 1 | 157 |
| 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 Ellipse A/S took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 6 | 6 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
Review panels
Most recent Ellipse A/S 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192951 | Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun | GEX | 2020-03-26 | 157 |
| K180406 | Ellipse Ydun | GEX | 2018-03-15 | 29 |
| K161162 | Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra | GEX | 2016-09-16 | 144 |
| K150907 | Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra | GEX | 2015-07-07 | 95 |
| K140670 | ELLIPSE I2PL+/ELLIPSE MULTIFLEX+ | ONF | 2014-09-25 | 191 |
| K081408 | ELLIPSE MULTIFLEX | GEX | 2008-10-17 | 151 |
| K072023 | ELLIPSE JUVIA, MODEL 9EJU7465 | GEX | 2007-09-12 | 51 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-05-05.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ellipse Technologies, Inc. (13 510(k)s)
- Ellipse Technologies, Incorporated (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ellipse A/S?
FDA lists 7 510(k) clearances under the applicant name “Ellipse A/S” (first 2007, latest 2020), across 2 product codes 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 Ellipse A/S?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ellipse A/S is 144 days.
Which FDA product codes appear under Ellipse A/S?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 6); ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, 1).
Next steps
- See all 7 Ellipse A/S clearances with predicates and recalls
- Run predicate analysis for product code GEX, Ellipse A/S'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.