NeedleZap Portable Needle Destruction Device
by E Med Future PMA
Active
PMA P010065
Overview
The NeedleZap is a Sharps Needle Destruction Device (generic name) designed to safely and permanently destroy previously used aluminum and stainless steel needles (gauge 16–30, 3⁄4–2 inches in length) attached to syringes. It is classified as a Class II medical device under FDA regulation 880.6210 and is intended for use in healthcare facilities and treatment settings to mitigate sharps injury risks.
This portable, single-use device is intended for healthcare professionals and operates in non-sterile environments. Supplied as a standalone unit, it requires no additional sterilization or maintenance beyond proper disposal after use. The device carries an FDA PMA approval (PMA number P010065) and is regulated under the MTV product code for sharps destruction systems. Storage and handling follow standard infection control protocols for sharps disposal equipment.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPRL | NumberP010065 | Date14 Mar 2003 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Full name
- Needle Zap
- Trade Name
- Needle Zap (R)
- 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
Questions
What types of needles can the NeedleZap safely destroy, and what are the size limitations?
The NeedleZap is designed to permanently destroy previously used aluminum and stainless steel needles attached to syringes. It accepts needles ranging from gauge 16 to 30 and lengths between 3⁄4 to 2 inches. This ensures compatibility with a wide variety of common syringe needles used in healthcare settings.
Is the NeedleZap reusable, or is it intended for single-use only?
The NeedleZap is explicitly a single-use device, meaning it is intended for one-time use only. After destroying needles, it must be disposed of properly to comply with infection control protocols and avoid reuse.
How should the NeedleZap be stored, and what precautions should be taken?
The NeedleZap should be stored following standard infection control protocols for sharps disposal equipment, as it is intended for use in non-sterile environments. Since it is single-use, it should be kept in a secure, clean location until use, and then disposed of appropriately after operation.
What regulatory approval does the NeedleZap hold, and how is it classified?
The NeedleZap holds an FDA Premarket Approval (PMA) under PMA number P010065. It is classified as a Class II medical device under FDA regulation 880.6210 and is regulated under the MTV product code for sharps destruction systems.