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)

GALILEOS IMPLANT, V 1.0

K-Number: K061472 · 2006-06-09

ApplicantSicat GmbH & Co. KG
Decision Date2006-06-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GALILEOS IMPLANT, V 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Sicat GmbH & Co. KG. It received FDA 510(k) clearance on 2006-06-09 under 510(k) number K061472. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALILEOS IMPLANT, V 1.0?

GALILEOS IMPLANT, V 1.0 is a medical device that received FDA 510(k) clearance on 2006-06-09. The listed applicant is Sicat GmbH & Co. KG. The 510(k) number is K061472.

When did GALILEOS IMPLANT, V 1.0 receive FDA 510(k) clearance?

GALILEOS IMPLANT, V 1.0 received FDA 510(k) clearance on 2006-06-09, under 510(k) number K061472.

Who is the listed applicant for GALILEOS IMPLANT, V 1.0?

The FDA 510(k) record lists Sicat GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GALILEOS IMPLANT, V 1.0?

The FDA product code for GALILEOS IMPLANT, V 1.0 is LLZ.

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 Sicat GmbH & Co. KG 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.

K192348SICAT Implant V2.0K180262SICAT EndoK153291SICAT OPTISLEEPK103723SICAT IMPLANT V1.2K093090GALILEOS IMPLANT, VERSION 1.7K090119SICAT IMPLANT

View all 7 devices →

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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.

↑