Medinol, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medinol, Ltd.” (first 1998, latest 2018), plus 3 PMA decisions, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 162 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 | 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, 510(k)s cleared under the name Medinol, Ltd. 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 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 Medinol, Ltd. is the 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 the product codes filed under Medinol, Ltd. (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 are listed under Medinol, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Medinol, Ltd.” (first 1998, latest 2018), plus 3 PMA decisions, across 4 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 Medinol, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medinol, Ltd. is 162 days.
Which FDA product codes appear under Medinol, Ltd.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 4); LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous, 2); MAF (Stent, Coronary, 2).
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. 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.