Endologix, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Endologix, LLC”, plus 3 PMA decisions, across 2 product codes in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | 2 | 0 |
| QWM | Stent Graft, Bypass, Superficial Femoral Artery | 1 | 0 |
Review panels
- Cardiovascular (3)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220021 | PMA | DETOUR System | 2023-06-07 |
| P120006 | PMA | OVATION ABDOMINAL STENT GRAFT SYSTEM | 2012-10-05 |
| P040002 | PMA | ENDOLOGIX POWERLINK SYSTEM | 2004-10-29 |
Recalls
openFDA lists no recalls under a recalling firm named Endologix, LLC.
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.
- Endologix, Inc. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Endologix, LLC?
FDA lists 0 510(k) clearances under the applicant name “Endologix, LLC”, plus 3 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Endologix, LLC?
The most frequent FDA product codes under this applicant name are MIH (System, Endovascular Graft, Aortic Aneurysm Treatment, 2); QWM (Stent Graft, Bypass, Superficial Femoral Artery, 1).
Next steps
- See all 0 Endologix, LLC clearances with predicates and recalls
- Run predicate analysis for product code MIH, Endologix, LLC'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.