FDA product code QGD

Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

Gastroenterology, Urology·Class 1·21 CFR 876.5290
US regulatory classifications
US Product Code (FDA)
QGD
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 876.5290
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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.

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About this record

Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.