Shepperd Trephine Set (GS-501-30-V)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K900612 ↗

FDA Product Code

HRX

FDA applicant

Downs Surgical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Valvotomy Knife

  Class I

  FDA 510(k) K843371 Active Cleared 25 Oct 1984

• Wellington Hospital Pattern Self-Retain

  Class I

  FDA 510(k) K843388 Active Cleared 1 Oct 1984

• Wilcox Rod & Plate Bender

  Not classified

  FDA 510(k) K840547 Active Cleared 31 Oct 1984

• Islam Sternal Puncture Needle, Cat # Af-594-00-V

  Class I

  FDA 510(k) K903748 Active Cleared 31 Oct 1990

• Sano Clip Appliers & Removers

  Class II

  FDA 510(k) K881912 Active Cleared 6 Jun 1988

• Downs Surgical Titanium Autocompression Plates

  Not classified

  FDA 510(k) K862945 Active Cleared 20 Aug 1986

See all devices from Downs Surgical, Ltd. →

• What is the Shepperd Trephine Set used for?

  The Shepperd Trephine Set is an orthopedic device designed for making the interior of a joint visible during surgical procedures. It functions as an electrically powered endoscope specifically for orthopedic applications.

• How is the Shepperd Trephine Set supplied?

  The device is supplied by Downs Surgical, Ltd. The data does not specify packaging details, sterility status, or whether it is single-use or reusable.

• What is the regulatory status of the Shepperd Trephine Set?

  The Shepperd Trephine Set is classified as a Class 2 medical device with FDA 510(k) clearance. It received clearance on October 22, 1990, with K number K900612. The device is not MRI safety rated.

• Are there different models or sizes available for the Shepperd Trephine Set?

  The device data only references the model GS-501-30-V. No information about different sizes or additional models is provided in the available specifications.