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FDA 510(k)

ENDOSCOPIC FIBEROPTIC CABLE

K-Number: K021931 · 2002-09-06

ApplicantGulf Medical Fiberoptics
Decision Date2002-09-06
Product CodeHBI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOSCOPIC FIBEROPTIC CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Gulf Medical Fiberoptics. It received FDA 510(k) clearance on 2002-09-06 under 510(k) number K021931. 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 ENDOSCOPIC FIBEROPTIC CABLE?

ENDOSCOPIC FIBEROPTIC CABLE is a medical device that received FDA 510(k) clearance on 2002-09-06. The listed applicant is Gulf Medical Fiberoptics. The 510(k) number is K021931.

When did ENDOSCOPIC FIBEROPTIC CABLE receive FDA 510(k) clearance?

ENDOSCOPIC FIBEROPTIC CABLE received FDA 510(k) clearance on 2002-09-06, under 510(k) number K021931.

Who is the listed applicant for ENDOSCOPIC FIBEROPTIC CABLE?

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

What is the FDA product code for ENDOSCOPIC FIBEROPTIC CABLE?

The FDA product code for ENDOSCOPIC FIBEROPTIC CABLE 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

Other records listing Gulf Medical Fiberoptics 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.

K061690SURGICAL HEADLIGHT

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, LLCK991208ENDOSCOPIC FIBEROPTIC CABLEIsolux AmericaK983277LIGHTSOURCE OR ILLUMINATOR MODEL I-100Cuda Products Co.

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.

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