Sharpx Needle Destruction Unit

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

Sharpx

Generic Name

Sharps needle destruction device

PMA Number

P980015 ↗

FDA Product Code

MTV

Device Class

Class II

Regulation

21 CFR Part 880.6210

Advisory Committee

General Hospital

FDA Decision

APRL

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• What types of needles can the Sharpx Needle Destruction Unit safely destroy, and where is it typically used?

  The Sharpx Needle Destruction Unit is designed to safely shred hypodermic needles ranging from 19 to 27 gauge and up to two inches in length. It is intended for use by healthcare professionals in out-patient and in-patient treatment settings, as well as clinical laboratories, to eliminate the risk of needle-stick injuries.

• Is the Sharpx Needle Destruction Unit reusable, and what storage conditions are required?

  The Sharpx is a single-use device and is non-sterile, meaning it cannot be reused. No special storage conditions are required beyond keeping it in a clean, dry environment before use.

• How was the Sharpx Needle Destruction Unit approved by the FDA, and what regulatory classification does it fall under?

  The Sharpx was approved under an FDA Premarket Approval (PMA) application (P980015), which is the regulatory route for Class II devices. It adheres to FDA regulation 880.6210 and is categorized under the General Hospital specialty with the product code MTV.

• What is the primary purpose of the Sharpx Needle Destruction Unit in clinical settings?

  The Sharpx is mechanically designed to permanently destroy used hypodermic needles, reducing the risk of needle-stick injuries for healthcare workers. It is not intended for any diagnostic or therapeutic use but rather as a safety device for sharps disposal.