SGV — Agent, Absorbable Hemostatic, Collagen With Polymeric Additives Class III

FDA Device Classification

FDA product code SGV covers "Agent, Absorbable Hemostatic, Collagen With Polymeric Additives", a Class III medical device regulated under 21 CFR 878.4490. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants.

Classification Details

Product Code
SGV
Device Class
Class III
Regulation Number
878.4490
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
Yes

Definition

An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood.