Endologix, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Endologix, Inc.” (first 1999, latest 2012), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 57 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 | 1 | 16 |
| 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | 3 | 3 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 0 |
Review panels
- Cardiovascular (6)
Most recent Endologix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120212 | AFX INTRODUCER SYSTEM | DYB | 2012-02-09 | 16 |
| K111747 | ENDOLOGIX AFX INTRODUCER SYSTEM | DYB | 2011-07-12 | 20 |
| K110090 | AFX INTRODUCER SYSTEM | DYB | 2011-05-26 | 134 |
| K080360 | ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER | DQY | 2008-04-08 | 57 |
| K991601 | DUAL LUMEN CATHETER, MODEL DL-35-90 | DQY | 1999-10-28 | 171 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970052 | PMA | FACT, ARC, LYNX AND GUARDIAN BALLOON CORONARY DILATATION CATHETERS | 1998-02-20 |
Recalls
26 product recalls in 13 recall events; 0 initiated in the last five years. Most recent: 2020-05-06.
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 Endologix, Inc. is the lead sponsor of 23 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT06315023: The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry) (Enrolling by invitation, started 2023-10-06)
- NCT06990048: The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System (Active not recruiting, started 2023-09-21)
- NCT05064540: JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization (Recruiting, started 2021-09-20)
- NCT04625660: Detour2 Continued Access Study (Completed, started 2021-04-07)
- NCT04252573: Chimney EndoVascular Aneurysm Sealing Of New Expanded Indication (Active not recruiting, started 2020-06-29)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Endologix, Inc. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
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, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Endologix, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Endologix, Inc.” (first 1999, latest 2012), plus 1 PMA decision, across 3 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 Endologix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Endologix, Inc. is 57 days.
Which FDA product codes appear under Endologix, Inc.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 3); DQY (Catheter, Percutaneous, 2); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 1).
Next steps
- See all 5 Endologix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Endologix, 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 (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.