FDA 510(k)

Biotex

K-Number: K180992 · 2019-07-16

Decision Date2019-07-16

Product CodeNBY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Biotex is the device name listed in this FDA 510(k) record. The listed applicant is Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2019-07-16 under 510(k) number K180992. The device is classified under product code NBY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Biotex?

Biotex is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Purgo Biologics, Inc.. The 510(k) number is K180992.

When did Biotex receive FDA 510(k) clearance?

Biotex received FDA 510(k) clearance on 2019-07-16, under 510(k) number K180992.

Who is the listed applicant for Biotex?

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

What is the FDA product code for Biotex?

The FDA product code for Biotex is NBY.

Other records listing Purgo Biologics, Inc. 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

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