Data / Medical devices / United States / Gulf Fiberoptics, Inc.

Gulf Fiberoptics, Inc.: FDA-registered device maker in Oldsmar, FL, United States, 2 510(k) clearances

Name: Gulf Fiberoptics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Gulf Fiberoptics, Inc. is registered with the FDA (registration 3003768921) in Oldsmar, FL, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 15, 2006. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Gulf Fiberoptics, Inc.

FDA registration number: 3003768921
Address: 448 Commerce Blvd, Oldsmar, FL, United States, 34677
Owner or operator: GULF FIBEROPTICS, INC (9051646)
Roles: Manufacturer
First device listed: December 3, 2007
Registered through: 2026
Brand names listed: Gulf Fiberoptics Rigid Endoscope Fiber Optic Light Cord, Gulf Fiberoptics Visualux 300T Xenon Light Source, Retractor Illumination Light Cable, Rigid Endoscope Fiber Optic Light Cord, Visualux Fiber Optic Surgical Headlight

Devices it lists

Device	Product code	Class	Role	Source
Illuminator, Fiberoptic, Surgical Field	HBI	2	Manufacturer	accessdata.fda.gov
Image, Illumination, Fiberoptic, For Endoscope	FFS	2	Manufacturer	accessdata.fda.gov
Light Source, Endoscope, Xenon Arc	GCT	2	Manufacturer	accessdata.fda.gov
Light, Surgical, Fiberoptic	FST	2	Manufacturer	accessdata.fda.gov
Retractor, Fiberoptic	FDG	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 15, 2006	K061690	SURGICAL HEADLIGHT	FST	Substantially Equivalent	Gulf Medical Fiberoptics	accessdata.fda.gov
September 6, 2002	K021931	ENDOSCOPIC FIBEROPTIC CABLE	HBI	Substantially Equivalent	Gulf Medical Fiberoptics	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 9, 2012	62408	Class II	Terminated	GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.	The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.	accessdata.fda.gov
May 13, 2011	58983	Not yet classified	Terminated	Surgical Headlight labeled in part Gulf Medical FiberopticsOLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical Headlight is a passive	Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight, headgear and fiber cable with 70% isopropyl alcohol had not been validated.	accessdata.fda.gov

Compare with other makers

Updated July 18, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.