PCU — Pancreatic Stent, Covered, Metallic, Removable Class II
FDA product code PCU covers "Pancreatic Stent, Covered, Metallic, Removable", a Class II medical device regulated under 21 CFR 876.5015. Submissions are reviewed by the Gastroenterology, Urology panel. Devices under this code are implants. At least 11 recent 510(k) clearances have been granted under this product code.
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 |