K220112 is an FDA 510(k) clearance for the AXIOS Stent and Electrocautery-Enhanced Delivery System. This device is classified as a Pancreatic Stent, Covered, Metallic, Removable (Class II - Special Controls, product code PCU).
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on September 7, 2022, 237 days after receiving the submission on January 13, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5015. To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts.
| 510(k) Number | K220112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 13, 2022 |
| Decision Date | September 07, 2022 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | PCU — Pancreatic Stent, Covered, Metallic, Removable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5015 |
| Definition | To Facilitate Transmural Endoscopic Drainage Of Pancreatic Pseudocysts |