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)

CONCORD 72

K-Number: K011626 · 2001-07-16

ApplicantGateway Alloys, Inc.
Decision Date2001-07-16
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONCORD 72 is the device name listed in this FDA 510(k) record. The listed applicant is Gateway Alloys, Inc.. It received FDA 510(k) clearance on 2001-07-16 under 510(k) number K011626. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCORD 72?

CONCORD 72 is a medical device that received FDA 510(k) clearance on 2001-07-16. The listed applicant is Gateway Alloys, Inc.. The 510(k) number is K011626.

When did CONCORD 72 receive FDA 510(k) clearance?

CONCORD 72 received FDA 510(k) clearance on 2001-07-16, under 510(k) number K011626.

Who is the listed applicant for CONCORD 72?

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

What is the FDA product code for CONCORD 72?

The FDA product code for CONCORD 72 is EJT.

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 Gateway Alloys, 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.

K011661CONCORD 88K011659GPW-SFK011628CONCORD 82K964941EL DORADO 40K964940TAOS 28K964950LA PLATA 28 (PM-28)

View all 31 devices →

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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.

↑