NIR BILIARY STENT
FDA 510(k) clearance K002130 · decided 2000-10-30
Clearance details
- K-number
- K002130
- Device name
- NIR BILIARY STENT
- Applicant
- Medinol, Ltd.
- Decision
- Unknown
- Date received
- 2000-07-14
- Decision date
- 2000-10-30
- Days to decision
- 108 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tel-Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S056) | Medinol, Ltd. | 2025-10-02 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S060) | Medinol, Ltd. | 2025-08-15 |
| EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (P170008/S059) | Medinol, Ltd. | 2025-08-07 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S058) | Medinol, Ltd. | 2025-07-03 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S057) | Medinol, Ltd. | 2025-05-30 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S055) | Medinol, Ltd. | 2024-11-26 |
| EluNIR & EluNIR-PERL Ridaforolimus Eluting Coronary Stent Systems (P170008/S049) | Medinol, Ltd. | 2024-08-27 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S052) | Medinol, Ltd. | 2024-08-07 |