FDA 510(k)

Zip 4 Skin Closure Device

K-Number: K170003 · 2017-08-18

Decision Date2017-08-18

Product CodePYO

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Zip 4 Skin Closure Device is a medical device manufactured by Zipline Medical, Inc.. It received FDA 510(k) clearance on 2017-08-18 under approval number K170003. The device is classified under product code PYO. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zip 4 Skin Closure Device?

Zip 4 Skin Closure Device is a medical device that received FDA 510(k) clearance on 2017-08-18. It is manufactured by Zipline Medical, Inc.. The 510(k) number is K170003.

When was Zip 4 Skin Closure Device approved by the FDA?

Zip 4 Skin Closure Device received FDA 510(k) clearance on 2017-08-18, under approval number K170003.

What company makes Zip 4 Skin Closure Device?

Zip 4 Skin Closure Device is manufactured by Zipline Medical, Inc..

What is the FDA product code for Zip 4 Skin Closure Device?

The FDA product code for Zip 4 Skin Closure Device is PYO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.