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)

FIBERLUME

K-Number: K901108 · 1990-03-28

ApplicantBurton
Decision Date1990-03-28
Product CodeHBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FIBERLUME is the device name listed in this FDA 510(k) record. The listed applicant is Burton. It received FDA 510(k) clearance on 1990-03-28 under 510(k) number K901108. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBERLUME?

FIBERLUME is a medical device that received FDA 510(k) clearance on 1990-03-28. The listed applicant is Burton. The 510(k) number is K901108.

When did FIBERLUME receive FDA 510(k) clearance?

FIBERLUME received FDA 510(k) clearance on 1990-03-28, under 510(k) number K901108.

Who is the listed applicant for FIBERLUME?

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

What is the FDA product code for FIBERLUME?

The FDA product code for FIBERLUME is HBI.

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

Related Devices (Code: HBI)

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.

K223183Light-Guide CablesOlympus Winter & Ibe GmbHK163185OptiLux LED IlluminatorIsolux, LLCK111342LIGHT GUIDE CABLESchott North AmericaK0529791125 XSB XENON FIBER-OPTIC LIGHT SOURCEIsolux, LLCK021931ENDOSCOPIC FIBEROPTIC CABLEGulf Medical FiberopticsK991208ENDOSCOPIC FIBEROPTIC CABLEIsolux America

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.

↑