Sharps Terminator Needle Destruction Device
PMA P120018
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP120018 | Date17 Feb 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Sharps Terminator
- Generic Name
- Sharps needle destruction device
- PMA Number
- FDA Product Code
- MTV
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6210
- Advisory Committee
- General Hospital
- FDA Decision
- APRL
Overview
AI-generated summary, 18 Sep 2026
The Sharps Terminator Needle Destruction Device is a Class II medical device designed for the safe destruction of used needles. It is classified as a sharps disposal device, specifically engineered to neutralise the hazard posed by 18- to 27-gauge needles up to 2 inches (5 cm) in length, reducing the risk of needlestick injuries in clinical settings.
This device is intended for use in healthcare environments, including treatment rooms, emergency/trauma rooms, wards, medication rooms, outpatient clinics, medical offices, dental offices, and clinical laboratories. Supplied as a single-use item, it requires no sterilisation and is regulated under FDA Premarket Approval (PMA) with PMA number P120018. Compliance with FDA guidelines ensures its safe integration into existing sharps management protocols.
Questions
AI-generated answers, 18 Sep 2026
What types of needles can the Sharps Terminator safely destroy, and what are the size limitations?
The Sharps Terminator is designed to safely destroy used needles ranging from 18 to 27 gauge, with a maximum length of 2 inches (approximately 5 cm). This ensures it can handle common needle sizes used in clinical settings while maintaining safety standards for needle destruction.
Is the Sharps Terminator meant for single-use or can it be reused?
The Sharps Terminator is explicitly supplied as a single-use device. This design choice eliminates the need for sterilization between uses and reduces the risk of contamination or device failure, ensuring consistent safety and reliability in healthcare environments.
Where can the Sharps Terminator be used, and what kinds of clinical settings is it intended for?
The device is intended for use in a variety of healthcare settings, including treatment rooms, emergency/trauma rooms, wards, medication rooms, outpatient clinics, medical offices, dental offices, and clinical laboratories. Its design aligns with sharps disposal protocols in these environments to minimize needlestick injury risks.
How is the Sharps Terminator regulated, and what approval process does it follow?
The Sharps Terminator is regulated under the FDA’s Premarket Approval (PMA) pathway, with an assigned PMA number (P120018). This approval ensures the device meets stringent safety and effectiveness standards for needle destruction, allowing it to be legally marketed and used in clinical settings as a Class II medical device.
Does the Sharps Terminator require any special handling or storage conditions?
Since the Sharps Terminator is a single-use device, no sterilization or special handling is required before use. However, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use. Proper disposal of the used device after activation is also recommended to comply with sharps disposal protocols.