21 CFR 876.5012 — Biliary Stent, Drain, And Dilator Accessories
Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5012
Identification
Biliary stent, drain, and dilator accessories are manual devices that aid in the introduction and connection of biliary stents, drains, or dilators. This generic type of device includes the guiding catheter, pushing catheter, pigtail straightener, flap protector, nasal transfer tube, and drainage connecting tube.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QGE | Biliary Stent, Drain, And Dilator Accessories | 1 | 0 |
