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FDA 510(k)

GUIDOR(TM)

K-Number: K912724 · 1993-05-13

ApplicantProcordia Oratech AB
Decision Date1993-05-13
Product CodeNPK
Advisory CommitteeDE
DecisionSubstantially Equivalent for Some Indications

Device Summary

GUIDOR(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Procordia Oratech AB. It received FDA 510(k) clearance on 1993-05-13 under 510(k) number K912724. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the GUIDOR(TM)?

GUIDOR(TM) is a medical device that received FDA 510(k) clearance on 1993-05-13. The listed applicant is Procordia Oratech AB. The 510(k) number is K912724.

When did GUIDOR(TM) receive FDA 510(k) clearance?

GUIDOR(TM) received FDA 510(k) clearance on 1993-05-13, under 510(k) number K912724.

Who is the listed applicant for GUIDOR(TM)?

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

What is the FDA product code for GUIDOR(TM)?

The FDA product code for GUIDOR(TM) is NPK.

Related Clinical Trials

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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 MedicinaisK222549OpenTexPurgo Biologics, Inc.K211554InnoGenic 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.

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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