Product code PYO— General Hospital
Zip 4 Skin Closure Device
- Classification name
- Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
- Device class
- Class 1
- Regulation
- 21 CFR 880.5240
- Advisory panel
- General Hospital
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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”
Market context for product code PYO
FDA has cleared device under product code PYO, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Top applicants under product code PYO
Recent clearances under product code PYO
Data sourced from openFDA. This site is unofficial and independent of the FDA.