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)

AIGIS-FINE

K-Number: K024143 · 2003-03-10

ApplicantSb Lucius, Inc.
Decision Date2003-03-10
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AIGIS-FINE is the device name listed in this FDA 510(k) record. The listed applicant is Sb Lucius, Inc.. It received FDA 510(k) clearance on 2003-03-10 under 510(k) number K024143. 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 AIGIS-FINE?

AIGIS-FINE is a medical device that received FDA 510(k) clearance on 2003-03-10. The listed applicant is Sb Lucius, Inc.. The 510(k) number is K024143.

When did AIGIS-FINE receive FDA 510(k) clearance?

AIGIS-FINE received FDA 510(k) clearance on 2003-03-10, under 510(k) number K024143.

Who is the listed applicant for AIGIS-FINE?

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

What is the FDA product code for AIGIS-FINE?

The FDA product code for AIGIS-FINE 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 Sb Lucius, 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.

K031010MIRACLE 98K024136AIGIS-SOFTK024135AIGIS-PLUSK024142AIGIS-SUPERK024145AIGIS-XOK024144AIGIS-PT

View all 15 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.

↑