Endoscopic Fiberoptic Cable

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

Fiber Optic Light Cable

Generic Name

Fibreoptic light cable, reusable

Device Name

Endoscopic Cable

Model / Reference

Endoscopic Cable-4.8mm x 9ft EUDAMED

4.8mm bundle diameter GUDID

9ft length GUDID

mono cable GUDID

Primary DI / UDI-DI

00857580006478

Basic UDI-DI

0857580006EC163

Direct Marketing DI

00857580006478

510(k) Number

K021931 ↗

FDA Product Code

HBI, FFS

EMDN Code

Z12029080 Various instruments for endoscopy and mini-invasive surgery - hardware accessories

GMDN Term

Fibreoptic light cable, reusable

Device Class

Class I EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 878.4580 510(k)GUDID

876.1500 GUDID

EU market of registration

France

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

Sterilization Method

Moist Heat or Steam Sterilization

• Surgical Headlight

  Class II

  FDA 510(k) K061690 Active Cleared 15 Sep 2006

• Is this fiberoptic cable designed for single-use or can it be reused in clinical settings?

  This device is explicitly labeled as a reusable component, intended for use in controlled clinical environments where strict sterility protocols are maintained. It is not designated for single-use, so proper cleaning, disinfection, and reprocessing procedures must be followed between procedures to ensure safe and effective use.

• What types of surgical procedures is this fiberoptic cable commonly used for?

  The Endoscopic Fiberoptic Cable is primarily designed to provide illumination during minimally invasive surgeries, including arthroscopy, laparoscopy, and plastic surgery interventions. Its flexible fiberoptic design allows for enhanced visualization in confined anatomical spaces, making it suitable for procedures where clear visibility is critical.

• How is this device regulated, and what does that mean for purchasing or clinical use?

  This device holds FDA 510(k) clearance (K021931) and complies with EU MDR (Medical Device Regulation) standards, classified as a Class II device under regulation number 878.4580. The clearance indicates it has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets U.S. safety and performance requirements. Clinically, this means it adheres to rigorous regulatory oversight, but reprocessing protocols must still follow facility-specific guidelines for reuse.

• Are there any size or model variations for this fiberoptic cable, and how would I determine the right fit for my procedures?

  The provided data does not specify explicit size or model variations for this device, but it is categorized under product code HBI and listed for general and plastic surgery applications. To determine the appropriate fit, consult the manufacturer’s technical documentation or contact Gulf Medical Fiberoptics directly, as compatibility may depend on the specific endoscopic system or surgical setup being used.

• Does this device have any restrictions on use with MRI equipment, or can it be used in MRI-compatible environments?

  The data explicitly states there are no specified MRI safety restrictions for this fiberoptic cable. However, since it is a reusable device, its use in MRI environments would depend on the broader compatibility of the entire surgical setup (e.g., endoscope, light source, and other connected equipment). Always verify the MRI safety of all components in the procedure to avoid interference or hazards.