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FDA 510(k)

G+ SYSTEM

K-Number: K113853 · 2012-05-08

ApplicantGlytec, LLC
Decision Date2012-05-08
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

G+ SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Glytec, LLC. It received FDA 510(k) clearance on 2012-05-08 under 510(k) number K113853. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G+ SYSTEM?

G+ SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-08. The listed applicant is Glytec, LLC. The 510(k) number is K113853.

When did G+ SYSTEM receive FDA 510(k) clearance?

G+ SYSTEM received FDA 510(k) clearance on 2012-05-08, under 510(k) number K113853.

Who is the listed applicant for G+ SYSTEM?

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

What is the FDA product code for G+ SYSTEM?

The FDA product code for G+ SYSTEM is NDC.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Glytec, LLC 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.

K254102GlucommanderK152300Glucommander

Related Devices (Code: NDC)

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.

K254102GlucommanderGlytec, LLCK260910EndoTool IV Cloud 1.0Glooko, Inc.K253512MiniMed Go AppMedtronic MinimedK253281UpDocUpdoc, Inc.K252104T1D1Comerge AGK241088EndoTool IV (3.1)Monarch Medical Technologies

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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