NOO · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5540
Classification
FDA Product Code
NOO
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 876.5540
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The device is a clamp used to close off needle holes in the arm of a Dialysis patient. The clamp applies uniform pressure to the sites of needle holes in the patient's arm until the holes close. The clamp pressure is designed to stop bleeding without causing blood clots. This is a different type of device than those listed in the classification regulation.