21 CFR 876.5016 — Gallbladder Drainage Stent And Delivery System
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5016
Identification
The AXIOS Stent and Electrocautery-Enhanced Delivery System is a prescription device intended to facilitate transgastric or transduodenal endoscopic drainage of the gallbladder in patients with acute cholecystitis who are at high risk for surgery. The system consists of a flexible, magnetic resonance conditional, fully covered, self-expanding, braided nitinol stent with two flanges and a silicone covering, preloaded into an electrocautery-enhanced delivery system with an integrated handle for positioning and deployment.
Classification Rationale
Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the risks to health.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QXH | Gallbladder Drainage Stent And Delivery System | 2 | 1 | Implant |
Special Controls
QXH — Gallbladder Drainage Stent And Delivery System
In combination with the general controls of the FD&C Act, the gallbladder drainage stent and delivery system is subject to the following special controls:
De Novo Order DEN230019
