# K170003: Zip 4 Skin Closure Device

- Pathway: 510(k) (Traditional)
- Applicant: Zipline Medical, Inc.
- Decided: Aug 18, 2017 after 227 days
- Product code: PYO (Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use)
- Device class: 1
- Regulation: 21 CFR 880.5240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 3M Company Steri-Strip Skin Closure Device: named in the summary without a submission number

## Indications for use
The Zip 4 Skin Closure Device is indicated for skin closure of minor lacerations.

Source page: https://510kreport.com/device/K170003
Methodology: https://510kreport.com/methodology