Medx Reusable Sharps Container

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K943771 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Sharptrack Reusable Sharps Container

  Class II

  FDA 510(k) K981184 Active Cleared 22 Jun 1998

• MX4000

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  FDA 510(k) K943794 Active Cleared 14 Dec 1994

• Medx Rotational Gantry System

  Class I

  FDA 510(k) K923356 Active Cleared 21 Sep 1992

• Med-X Model 301 X-Ray Filter

  Not classified

  FDA 510(k) K827761 Active Cleared 10 Aug 1982

• Multi-Format Film Camera

  Class II

  FDA 510(k) K843582 Active Cleared 25 Oct 1984

• What is the primary purpose of the Medx Reusable Sharps Container?

  This device is designed for the collection and containment of medical sharps waste. It provides a secure vessel specifically intended for the disposal of hypodermic needles and related sharp instruments within clinical environments.

• Is this sharps container intended for single-use or reuse?

  The Medx Reusable Sharps Container is designed for reusable applications. This allows clinical facilities to utilize the vessel multiple times for the containment of sharps waste, provided it is managed according to standard clinical waste protocols.

• What is the regulatory status of this device?

  The Medx Reusable Sharps Container is identified by FDA 510(k) number K943771. It was cleared under a traditional 510(k) submission process and determined to be substantially equivalent to existing devices within the General Hospital medical specialty.