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)

AURORA 53

K-Number: K964949 · 1997-01-13

ApplicantGateway Alloys, Inc.
Decision Date1997-01-13
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AURORA 53 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 1997-01-13 under 510(k) number K964949. 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 AURORA 53?

AURORA 53 is a medical device that received FDA 510(k) clearance on 1997-01-13. The listed applicant is Gateway Alloys, Inc.. The 510(k) number is K964949.

When did AURORA 53 receive FDA 510(k) clearance?

AURORA 53 received FDA 510(k) clearance on 1997-01-13, under 510(k) number K964949.

Who is the listed applicant for AURORA 53?

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 AURORA 53?

The FDA product code for AURORA 53 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.

K011659GPW-SFK011661CONCORD 88K011628CONCORD 82K011626CONCORD 72K964941EL DORADO 40K964948AURORA 52 (PM-01)

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.

↑