Light Handle, Surgical

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Welcon Light Handle

510(k) Number

K894397 ↗

FDA Product Code

FTA

Device Class

Class II

Regulation

21 CFR Part 878.4580

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Sterile Water for Device Irrigation/ Sterile Saline for Device Irrigation

  Class II

  FDA 510(k) K973734 Active Cleared 5 Feb 1998

• Welcon Hue-Vu Urinary Drainage Bag

  Class II

  FDA 510(k) K971764 Active Cleared 29 Jul 1997

• Sterile Catherization Procedure Trays

  Class II

  FDA 510(k) K830359 Active Cleared 17 Mar 1983

• Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device Irrigation

  Class II

  FDA 510(k) K003402 Active Cleared 1 May 2001

• Sterile Irrigating Syringes, Kits, Tray

  Class I

  FDA 510(k) K813027 Active Cleared 20 Nov 1981

• Women and Infant's Delivery Pack

  Class II

  FDA 510(k) K912869 Active Cleared 4 Dec 1991

See all devices from Welcon, Inc. →

• What is the Welcon Light Handle Surgical used for?

  The Welcon Light Handle Surgical is designed to enhance visibility during operative procedures in general and plastic surgery. It directs a focused light source to the surgical field, ensuring clear illumination of the area of interest. This is particularly useful in procedures where precise visualization is critical, such as tissue dissection or suturing.

• Is the Welcon Light Handle Surgical a single-use or reusable device?

  The Welcon Light Handle Surgical is intended for reuse. It is supplied as a reusable instrument and must be maintained in a sterile surgical environment during use. Reusability requires proper cleaning, sterilization, and storage procedures to ensure safety and functionality.

• What are the key specifications for the Welcon Light Handle Surgical?

  The device falls under FDA regulation number 878.4580 and was cleared under 510(k) submission K894397. It is classified as a Class II medical device and is intended for use in sterile surgical environments. No specific MRI safety or additional storage instructions are provided in the regulatory data.

• How is the Welcon Light Handle Surgical supplied, and what are the handling requirements?

  The Welcon Light Handle Surgical is supplied as a reusable instrument, meaning it is designed for multiple uses after proper cleaning and sterilization. Since it is intended for sterile surgical environments, it must be handled with care to maintain sterility before and during use. No additional storage instructions are specified beyond standard surgical instrument protocols.

• Is the Welcon Light Handle Surgical approved for use in specific medical specialties?

  Yes, the Welcon Light Handle Surgical is specifically intended for use in general and plastic surgery. The device’s design and FDA clearance reflect its suitability for these specialties, where focused illumination is essential for precise surgical techniques.