Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
FDA 510(k) clearance K223592 · decided 2022-12-29
Clearance details
- K-number
- K223592
- Device name
- Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-12-01
- Decision date
- 2022-12-29
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Axonics Sacral Neuromodulation System (P180046/S113) | Boston Scientific Corporation | 2026-08-07 |
| Axonics Sacral Neuromodulation System (P190006/S113) | Boston Scientific Corporation | 2026-08-07 |
| Innova Self Expanding Stent System (P140028/S087) | Boston Scientific Corporation | 2026-08-06 |
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| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S009) | Boston Scientific Corporation | 2026-07-30 |
| Axonics Sacral Neuromodulation System (P180046/S110) | Boston Scientific Corporation | 2026-07-24 |
| Axonics Sacral Neuromodulation System (P190006/S110) | Boston Scientific Corporation | 2026-07-24 |
| S-ICD EMBLEM GEN 2 (A209); S-ICD EMBLEM MRI (A219) (P110042/S215) | Boston Scientific Corporation | 2026-07-23 |