QGC · Suprapubic Catheter Accessories
Gastroenterology, Urology · 21 CFR 876.5100 · Class 1
Overview
| Product Code | QGC |
|---|---|
| Device Name | Suprapubic Catheter Accessories |
| Regulation | 21 CFR 876.5100 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.
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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
