Cleared Traditional

K170003 - Zip 4 Skin Closure Device (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K170003 · Zipline Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2017
Decision
227d
Days
Class 1
Risk

K170003 is an FDA 510(k) clearance for the Zip 4 Skin Closure Device. Classified as Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use (product code PYO), Class I - General Controls.

Submitted by Zipline Medical, Inc. (Campbell, US). The FDA issued a Cleared decision on August 18, 2017 after a review of 227 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Zipline Medical, Inc. devices

Submission Details

510(k) Number K170003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2017
Decision Date August 18, 2017
Days to Decision 227 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 114d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PYO Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.