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QGDClass I

Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories

21 CFR 876.5290 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QGD is the FDA product code for Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories, a class I device type, regulated under 21 CFR 876.5290. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QGD
Device name
Implanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories
FDA 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.
Regulation
21 CFR 876.5290
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code