FDA 510(k)

EndoVac Pure

K-Number: K162436 · 2016-12-21

Decision Date2016-12-21

Product CodeNYL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

EndoVac Pure is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162436. The device is classified under product code NYL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoVac Pure?

EndoVac Pure is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Kerr Corporation. The 510(k) number is K162436.

When did EndoVac Pure receive FDA 510(k) clearance?

EndoVac Pure received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162436.

Who is the listed applicant for EndoVac Pure?

The FDA 510(k) record lists Kerr Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EndoVac Pure?

The FDA product code for EndoVac Pure is NYL.

Other records listing Kerr Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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