QGD · Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
Gastroenterology, Urology · 21 CFR 876.5290 · Class 1
Overview
| Product Code | QGD |
|---|---|
| Device Name | Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories |
| Regulation | 21 CFR 876.5290 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
Implanted mechanical/hydraulic urinary continence device surgical accessories are manual devices designed to be used for surgical procedures associated with the implantation of an implanted mechanical/hydraulic urinary continence device. This generic type of device includes the measurement tool or tape, connector assembly tool, tubing plug, incision closing tool, tubing passer, blunt needle, and hemostat shod tubing.
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.
