Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OpenTex

K-Number: K222549 · 2023-05-11

ApplicantPurgo Biologics, Inc.
Decision Date2023-05-11
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OpenTex 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 2023-05-11 under 510(k) number K222549. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OpenTex?

OpenTex is a medical device that received FDA 510(k) clearance on 2023-05-11. The listed applicant is Purgo Biologics, Inc.. The 510(k) number is K222549.

When did OpenTex receive FDA 510(k) clearance?

OpenTex received FDA 510(k) clearance on 2023-05-11, under 510(k) number K222549.

Who is the listed applicant for OpenTex?

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 OpenTex?

The FDA product code for OpenTex is NPK.

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.

K230305THE Graft CollagenK230091THE CoverK191737The Graft Bone SubstituteK180992BiotexK173188The Graft Natural Bone Substitute

Related Devices (Code: NPK)

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.

K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos MedicinaisK211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmSalvin Dental Specialties

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.

↑