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FDA 510(k)

Zip 4 Skin Closure Device

K-Number: K170003 · 2017-08-18

ApplicantZipline Medical, Inc.
Decision Date2017-08-18
Product CodePYO
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Zip 4 Skin Closure Device is the device name listed in this FDA 510(k) record. The listed applicant is Zipline Medical, Inc.. It received FDA 510(k) clearance on 2017-08-18 under 510(k) 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. The listed applicant is Zipline Medical, Inc.. The 510(k) number is K170003.

When did Zip 4 Skin Closure Device receive FDA 510(k) clearance?

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

Who is the listed applicant for Zip 4 Skin Closure Device?

The FDA 510(k) record lists Zipline Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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.

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