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FDA 510(k)

Biotex

K-Number: K180992 · 2019-07-16

ApplicantPurgo Biologics, Inc.
Decision Date2019-07-16
Product CodeNBY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Biotex is a medical device manufactured by Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2019-07-16 under approval 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. It is manufactured by Purgo Biologics, Inc.. The 510(k) number is K180992.

When was Biotex approved by the FDA?

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

What company makes Biotex?

Biotex is manufactured by Purgo Biologics, Inc..

What is the FDA product code for Biotex?

The FDA product code for Biotex is NBY.

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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.

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