510(k) K170003

Zip 4 Skin Closure Device by Zipline Medical, Inc. — Product Code PYO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 18, 2017
Date Received: January 3, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Device Class: Class I
Regulation Number: 880.5240
Review Panel: SU
Submission Type

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