PCU — Pancreatic Stent, Covered, Metallic, Removable Class II
Classification Details
- Product Code
- PCU
- Device Class
- Class II
- Regulation Number
- 876.5015
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- Yes
Definition
To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252648 | taewoong medical co | Niti-S SPAXUS Stent | March 13, 2026 |
| K220112 | boston scientific corporation | AXIOS Stent and Electrocautery-Enhanced Delivery System | September 7, 2022 |
| K203132 | boston scientific corporation | AXIOS Stent and Electrocautery Enhanced Delivery System | April 15, 2021 |
| K192043 | boston scientific corporation | AXIOS Stent and Electrocautery Enhanced Delivery System | August 26, 2019 |
| K181905 | boston scientific corporation | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Deliver | March 25, 2019 |
| K163272 | boston scientific corporation | AXIOS Stent and Electrocautery Enhanced Delivery System | February 18, 2017 |
| K153088 | boston scientific corporation | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Deli | December 11, 2015 |
| K152572 | boston scientific corporation | AXIOS Stent and Delivery System | October 6, 2015 |
| K150692 | boston scientific | AXIOS Stent with Electrocautery Enhanced Delivery System | August 5, 2015 |
| K140561 | xlumena | AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVER | April 23, 2014 |
| DEN130007 | xlumena | AXIOS STENT AND DELIVERY SYSTEM | December 18, 2013 |