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FDA 510(k)

Ontex and other proprietary names

K-Number: K162746 · 2017-03-03

ApplicantOntex Bvba
Decision Date2017-03-03
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Ontex and other proprietary names is the device name listed in this FDA 510(k) record. The listed applicant is Ontex Bvba. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K162746. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ontex and other proprietary names?

Ontex and other proprietary names is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Ontex Bvba. The 510(k) number is K162746.

When did Ontex and other proprietary names receive FDA 510(k) clearance?

Ontex and other proprietary names received FDA 510(k) clearance on 2017-03-03, under 510(k) number K162746.

Who is the listed applicant for Ontex and other proprietary names?

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

What is the FDA product code for Ontex and other proprietary names?

The FDA product code for Ontex and other proprietary names is HEB.

Other records listing Ontex Bvba 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.

Related Devices (Code: HEB)

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.

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.