Elliquence, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Elliquence, LLC” (first 2010, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 96 days, against 110 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 265 |
| 2014 | 0 | — |
| 2015 | 1 | 428 |
| 2016 | 1 | 59 |
| 2017 | 2 | 116 |
| 2018 | 1 | 80 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 51 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Elliquence, LLC took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| HRX | Arthroscope | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
Review panels
Most recent Elliquence, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243739 | AxCess® Expandable Interbody System | MAX | 2025-01-24 | 51 |
| K180766 | Endiscope, Endiscope Cervical | HRX | 2018-06-11 | 80 |
| K170107 | Surgi Max Ultra | GEI | 2017-05-03 | 111 |
| K162490 | Disc-FX System | GEI | 2017-01-06 | 121 |
| K160041 | Cobbra RF Tissue Dissector | GEI | 2016-03-07 | 59 |
| K142410 | Elliquence Electrodes | GEI | 2015-10-30 | 428 |
| K130110 | MEDDUSA BIPOLAR SYSTEM | GEI | 2013-10-08 | 265 |
| K100390 | SURGIMAX/ SURGIMAX PLUS | GEI | 2010-08-25 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Elliquence, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Elliquence, LLC?
FDA lists 8 510(k) clearances under the applicant name “Elliquence, LLC” (first 2010, latest 2025), across 3 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 Elliquence, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Elliquence, LLC is 116 days. Since 2017: 96 days, versus 110 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Elliquence, LLC?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); HRX (Arthroscope, 1); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Next steps
- See all 8 Elliquence, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEI, Elliquence, 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, 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.