Relievant Medsystems: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Relievant Medsystems” (first 2007, latest 2022), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 107 days. Since 2017 the median was 107 days, against 113 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 240 |
| 2017 | 2 | 132 |
| 2018 | 1 | 214 |
| 2019 | 1 | 63 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 90 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Relievant Medsystems took a median 107 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXI | Probe, Radiofrequency Lesion | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| GXD | Generator, Lesion, Radiofrequency | 1 | 1 |
Review panels
Most recent Relievant Medsystems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222281 | Intracept Intraosseous Nerve Ablation System | GXI | 2022-10-26 | 89 |
| K213836 | Intracept Intraosseous Nerve Ablation System | GXI | 2022-03-11 | 92 |
| K190504 | Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator | GXI | 2019-05-03 | 63 |
| K180369 | Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) | GXI | 2018-09-14 | 214 |
| K171143 | Relievant Medsystems RF Generator | GXD | 2017-08-18 | 122 |
| K170827 | INTRACEPT Intraosseous Nerve Ablation System | GXI | 2017-08-09 | 142 |
| K153272 | INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set | GXI | 2016-07-09 | 240 |
| K100641 | INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) | GEI | 2010-03-30 | 25 |
| K083856 | INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 | GEI | 2009-01-22 | 29 |
| K070443 | INTRACEPT BI-POLAR RF PROBE, MODEL 04814 | GEI | 2007-10-05 | 232 |
Recalls
openFDA lists no recalls under a recalling firm named Relievant Medsystems.
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 Relievant Medsystems is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03997825: Five-Plus Year Follow-Up of SMART Randomized Controlled Trial (Completed, started 2019-06-13)
- NCT03266107: Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain (Completed, started 2018-02-14)
- NCT03246061: INTRACEPT: Prospective, Randomized, Multi-center Study Intraosseous Basivertebral Nerve Ablation for Treatment of CLBP (Completed, started 2017-08-24)
- NCT01446419: SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain (Completed, started 2011-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Relievant Medsystems?
FDA lists 10 510(k) clearances under the applicant name “Relievant Medsystems” (first 2007, latest 2022), 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 Relievant Medsystems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Relievant Medsystems is 107 days. Since 2017: 107 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Relievant Medsystems?
The most frequent FDA product codes under this applicant name are GXI (Probe, Radiofrequency Lesion, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); GXD (Generator, Lesion, Radiofrequency, 1).
Next steps
- See all 10 Relievant Medsystems clearances with predicates and recalls
- Run predicate analysis for product code GXI, Relievant Medsystems'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.