FDA Product Code
FDA Product Code PCU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5015
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252648 | Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. | 2026-03-13 | Traditional | PDF ↗ |
| K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery System | Boston Scientific Corporation | 2022-09-07 | Traditional | PDF ↗ |
| K203132 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2021-04-15 | Traditional | PDF ↗ |
| K192043 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2019-08-26 | Traditional | PDF ↗ |
| K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2019-03-25 | Traditional | PDF ↗ |
| K163272 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2017-02-18 | Traditional | PDF ↗ |
| K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System | Boston Scientific Corporation | 2015-12-11 | Traditional | PDF ↗ |
| K152572 | AXIOS Stent and Delivery System | Boston Scientific Corporation | 2015-10-06 | Special | PDF ↗ |
| K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | 2015-08-05 | Traditional | PDF ↗ |
| K140561 | AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) | Xlumena, Inc. | 2014-04-23 | Special | PDF ↗ |
| DEN130007 | AXIOS STENT AND DELIVERY SYSTEM | Xlumena, Inc. | 2013-12-18 | Post-NSE | — |
Product code PCU · Class II · Gastroenterology, Urology. Data: openFDA.