Pain Doc

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K941342 ↗

FDA Product Code

GZB

Device Class

Class II

Regulation

21 CFR Part 882.5880

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Orion Red Urethral Catheter

  Class II

  FDA 510(k) K944383 Active Cleared 6 Dec 1994

• Dial Medical Supply Sharps Container

  Class II

  FDA 510(k) K944230 Active Cleared 7 Nov 1994

• Accuflex Dynamic Elbow Orthosis

  Class I

  FDA 510(k) K926391 Active Cleared 22 Jul 1993

• Orion's Foley Catheterization Kit with Catheter and Bag

  Class I

  FDA 510(k) K944379 Active Cleared 15 Feb 1995

• Well Lead Tracheostomy Tube and Disposable Inner Cannula

  Class II

  FDA 510(k) K101721 Active Cleared 24 Mar 2011

• Orion Foley Catheter

  Class II

  FDA 510(k) K944380 Active Cleared 30 Nov 1994

See all devices from Regulatory & Marketing Services, Inc. →