Valvotomy Knife

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K843371 ↗

FDA Product Code

EMF

FDA applicant

Downs Surgical , Ltd.

Device Class

Class I

Regulation

21 CFR Part 878.4800

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• 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

• Shepperd Straight and Curved Needles

  Class II

  FDA 510(k) K900609 Active Cleared 22 Oct 1990

See all devices from Downs Surgical, Ltd. →