21 CFR 876.5290 — Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5290

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories10
Innolitics

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