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Kogent Spetzler Lighted Suction Tubes

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141781

by Katalyst Surgical, Llc

Identifiers

510(k) Number
K141781 FDA 510(k)
FDA Product Code
HBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4580 FDA 510(k)
Regulation Number
878.4580 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Kogent Spetzler Lighted Suction Tubes are fiberoptic surgical field illuminators designed for use with suction devices. These devices combine aspiration functionality with localized illumination, enabling enhanced visibility in narrow or deep surgical fields where standard lighting may be obstructed. They fall under the classification of fiberoptic surgical field illuminators and are intended for use in general and plastic surgery procedures.

These tubes are disposable, single-use devices that connect to standard operating room suction systems and external high-intensity light sources via a 12-foot fiberoptic cable. They are intended for use in clinical and operating room settings by surgeons or surgical staff. The devices are FDA-cleared under the 510(k) pathway and comply with regulation number 878.4580. They are supplied sterile and intended for one-time use per manufacturer specifications.

Frequently asked questions

What is the Kogent Spetzler Lighted Suction Tube used for?

The Kogent Spetzler Lighted Suction Tube combines suction functionality with localized fiberoptic illumination to enhance visibility in narrow or deep surgical fields. This design is particularly useful in general and plastic surgery procedures where standard lighting may be obstructed, allowing surgeons to better visualize and navigate challenging areas during aspiration.

How are these suction tubes supplied and prepared for use?

The Kogent Spetzler Lighted Suction Tubes are supplied sterile and intended for single-use only, as specified by the manufacturer. Each tube connects to standard operating room suction systems via a 12-foot fiberoptic cable, which also links to an external high-intensity light source. This setup ensures the device is ready for immediate use upon opening the sterile packaging.

Are these tubes reusable, or must they be discarded after one use?

These tubes are explicitly designed for single-use only. The manufacturer’s specifications emphasize that they are disposable, ensuring sterility and safety for each procedure. Reuse is not recommended or supported by the manufacturer to maintain clinical standards and prevent contamination.

What sizes or models are available for the Kogent Spetzler Lighted Suction Tubes?

The provided data does not specify individual sizes or model variants beyond the general product name. However, the device is categorized under FDA product code HBI (Fiberoptic Illuminators) and includes multiple registration numbers, indicating potential variations in design or length. For precise sizing or model-specific details, refer to the manufacturer’s catalog or technical documentation.

How should these suction tubes be stored before use?

Since the tubes are sterile and single-use, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the sterility barrier remains intact until use. Always check the packaging for expiration dates or integrity before opening.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lighted Suctions | Kogent Surgical, KOGENT SPETZLER LIGHTED SUCTION TUBES (K141781) — FDA 510(k) | Innolitics, Surgical Instruments | Kogent Surgical | Chesterfield MO

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Katalyst Surgical, Llc

Sources (1)

  • FDA 510(k) K141781 24 fields · synced Oct 1, 2026