Medinol, Ltd.: FDA clearances and approvals
Medinol, Ltd. has 6 FDA 510(k) clearances (first 1998, latest 2018), plus 3 PMA decisions, across 4 product codes in 2 review panels. Median 510(k) review time: 162 days. It is the industry lead sponsor of 13 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 352 |
| 2017 | 1 | 141 |
| 2018 | 1 | 66 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Medinol, Ltd.'s cleared 510(k)s took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 4 | 4 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 2 | 2 |
| MAF | Stent, Coronary | 2 | 0 |
| NIQ | Coronary Drug-Eluting Stent | 1 | 0 |
Review panels
Most recent Medinol, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173581 | Gallant PTCA Dilatation Catheter | LOX | 2018-01-25 | 66 |
| K162434 | NC Gallant PTCA Catheter | LOX | 2017-01-19 | 141 |
| K150487 | X-Suit NIR Biliary Metallic Stent | FGE | 2016-02-12 | 352 |
| K081956 | MEDINOL X-SUIT NIR BILIARY METALLIC STENT | FGE | 2009-01-09 | 184 |
| K002130 | NIR BILIARY STENT | FGE | 2000-10-30 | 108 |
| K973171 | NIR BILIARY STENT | FGE | 1998-11-13 | 445 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P170008 | PMA | EluNIR Ridaforolimus Eluting Coronary Stent System | 2017-11-28 |
| P110004 | PMA | PRESILLION PLUS COCR CORONARY STENT RX SYSTEM | 2012-04-12 |
| P020040 | PMA | NIRFLEX PREMOUNTED STENT | 2003-10-24 |
Recalls
openFDA lists no recalls under a recalling firm named Medinol, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Medinol, Ltd. is the industry lead sponsor of 13 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06410313: First In Human Study to Assess Safety and Efficacy of the ChampioNIR™ Drug Eluting Peripheral Stent in the Treatment of Patients With Superficial Femoral Artery Disease and/or Proximal Popliteal Artery Disease (Recruiting, started 2024-08-15)
- NCT05364697: IonMAN Trial- First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System (Active not recruiting, started 2022-08-30)
- NCT04761939: BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial (Completed, started 2020-12-31)
- NCT03877848: EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study (Completed, started 2019-05-06)
- NCT03702608: BIONICS 38 mm Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial (Completed, started 2018-11-14)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Medinol, Ltd.'s product codes (a text match, not an official crosswalk):
- C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
Frequently asked questions
How many FDA 510(k) clearances does Medinol, Ltd. have?
Medinol, Ltd. has 6 FDA 510(k) clearances (first 1998, latest 2018), plus 3 PMA decisions, across 4 product codes in 2 review panels.
How long does FDA take to clear Medinol, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Medinol, Ltd.'s cleared 510(k)s is 162 days.
What devices does Medinol, Ltd. make?
Its most frequent FDA product codes are FGE (Stents, Drains And Dilators For The Biliary Ducts, 4); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 2); MAF (Stent, Coronary, 2).
Has Medinol, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Medinol, Ltd. Related entities may recall under other names.
Next steps
- See all 6 Medinol, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Medinol, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.