Needle Counter-Sure Count/30 CT. Magn.

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K801257 ↗

FDA Product Code

BXX

Device Class

Class I

Regulation

21 CFR Part 868.2620

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Cautery Tip Cleaning Pad

  Not classified

  FDA 510(k) K853315 Active Cleared 21 Aug 1985

• Needle Counter-Sure Count/100 Count

  Class II

  FDA 510(k) K801259 Active Cleared 9 Jun 1980

• Suture Rack & Needle Counter

  Class I

  FDA 510(k) K760428 Active Cleared 2 Nov 1976

• Saddlebag Instrument Pad W/Pouches

  Not classified

  FDA 510(k) K821395 Active Cleared 3 Jun 1982

• Sure Count 30 Count Foam & Magnetic 92-3030

  Not classified

  FDA 510(k) K853622 Active Cleared 10 Oct 1985

• Sure-Count 15 Count Needle Counter

  Not classified

  FDA 510(k) K852257 Active Cleared 26 Jun 1985

See all devices from Kleen Test Products Corporation →