Malleable Ptfe Coated Brain Spatulae

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K880278 ↗

FDA Product Code

HAO

FDA applicant

Downs Surgical , Ltd.

Device Class

Class I

Regulation

21 CFR Part 882.4535

Advisory Committee

Neurology

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. →