510(k) K170003
K170003 is an FDA 510(k) premarket notification submitted by Zipline Medical, Inc. for the device "Zip 4 Skin Closure Device". The FDA issued a decision of Substantially Equivalent on August 18, 2017. The device falls under product code PYO (Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use), a Class I device regulated under 21 CFR 880.5240.
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