Gulf Fiberoptics, Inc.

Oldsmar, FL, US

GULF FIBEROPTICS, INC. appears in FDA device records in Oldsmar, FL. FDA records list 2 510(k) clearances between 2002-09-06 and 2006-09-15, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 2 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 2
Registered establishments: 1

FDA records under these names

1 name

FDA records resolved to Gulf Fiberoptics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Gulf Medical Fiberoptics510(k), recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Gulf Fiberoptics, Inc. between 2002 and 2006. The busiest year on record is 2002, with 1. The most recent is 2006, with 1.

Clearances by year, as a table

510(k) clearance decisions for Gulf Fiberoptics, Inc., by decision year
Year	Clearances
2002	1
2006	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K061690	SURGICAL HEADLIGHT	FST	Substantially Equivalent	2006-09-15
K021931	ENDOSCOPIC FIBEROPTIC CABLE	HBI	Substantially Equivalent	2002-09-06

Registered establishments

FDA registered establishments for Gulf Fiberoptics, Inc., with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3003768921	3003768921	GULF FIBEROPTICS, INC.	448 Commerce Blvd, OLDSMAR, FL 34677 US	2026	FDG FFS FST GCT HBI

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2029-2012	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.	Class II	2012-04-09	Terminated
Z-0831-2012	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 luminaire. It is illuminated by a source of light by way of the fiber optics and provides supplemental lighting for medical and surgical procedures.	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.		2011-05-13	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain