PYO — Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use Class I

FDA Device Classification

Classification Details

Product Code
PYO
Device Class
Class I
Regulation Number
880.5240
Submission Type
Review Panel
SU
Medical Specialty
General Hospital
Implant
No

Definition

A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K170003zipline medicalZip 4 Skin Closure DeviceAugust 18, 2017