Epidural Minipack

No FDA recalls found in the data synced 10 Oct 2026.

510(k) Number

K924541 ↗

FDA Product Code

BYO

Device Class

Class I

Regulation

21 CFR Part 868.5220

Advisory Committee

Anesthesiology

FDA Decision

SESK Substantially Equivalent — Kit

• Suction Control Valve

  Class I

  FDA 510(k) K892343 Active Cleared 24 Apr 1989

• Accu-Vent(Tm) with Needle-Pro(Tm)

  Class I

  FDA 510(k) K912043 Active Cleared 5 Jul 1991

• Needle-Pro Cartridge

  Class II

  FDA 510(k) K923127 Active Cleared 29 Apr 1993

• Subcutaneous Tunneling Needle and Handles

  Class II

  FDA 510(k) K930218 Active Cleared 27 Jul 1993

• Heat Moisture Condenser

  Class I

  FDA 510(k) K923910 Active Cleared 26 Jan 1993

• Anesthesia Breathing Circuit

  Class I

  FDA 510(k) K915452 Active Cleared 14 Feb 1992

See all devices from Concord/Portex →