OpenTex
K-Number: K222549 · 2023-05-11
ApplicantPurgo Biologics, Inc.
Decision Date2023-05-11
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OpenTex is a medical device manufactured by Purgo Biologics, Inc.. It received FDA 510(k) clearance on 2023-05-11 under approval 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. It is manufactured by Purgo Biologics, Inc.. The 510(k) number is K222549.
When was OpenTex approved by the FDA?
OpenTex received FDA 510(k) clearance on 2023-05-11, under approval number K222549.
What company makes OpenTex?
OpenTex is manufactured by Purgo Biologics, Inc..
What is the FDA product code for OpenTex?
The FDA product code for OpenTex is NPK.
Other Devices by Purgo Biologics, Inc.
Related Devices (Code: NPK)
K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mmSalvin Dental Specialties
K171774RPM Reinforced PTFE MeshOsteogenics Biomedical, Inc.
K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc.
K210797Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd.
K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais
K211554InnoGenic Non-resorbable MembraneCowellmedi Co., Ltd.
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.