Needle Remover
by Howard, Hills & Harsh 510(k)
Active
510(k) K881866
Overview
The Needle Remover is a device designed to safely and securely remove used hypodermic needles from patients after injection. Classified under the product code FMF, it is intended to reduce the risk of needle-stick injuries by facilitating the separation of the needle from the syringe or hub, allowing for safe disposal in a sharps container.
This device is supplied as a reusable medical instrument and is intended for use in general hospital settings. It requires no specific sterility beyond standard cleaning protocols between uses. The device is not MRI-compatible and is available in a single configuration as referenced by the FDA 510(k) clearance (K881866). Storage should follow manufacturer guidelines for reusable medical instruments to maintain functionality and hygiene.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881866 | Date14 Nov 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Howard, Hills & Harsh
Questions
What is the Needle Remover designed to do in a clinical setting and how does it help reduce workplace hazards?
The Needle Remover is specifically engineered to safely detach used hypodermic needles from syringes or hubs after injection, minimizing the risk of needle-stick injuries. By facilitating this separation, it allows healthcare workers to dispose of the needle in a sharps container without direct handling, thereby reducing exposure to potential bloodborne pathogens and improving workplace safety.
Is the Needle Remover intended for single-use or can it be reused in a hospital environment?
The Needle Remover is designed as a reusable medical instrument for use in general hospital settings. It does not require sterile packaging for each use, but standard cleaning protocols between uses are necessary to maintain functionality and hygiene, as outlined in the manufacturer’s guidelines.
What storage instructions should be followed for the Needle Remover to ensure proper functionality and cleanliness?
The Needle Remover should be stored according to standard manufacturer guidelines for reusable medical instruments. This typically includes keeping it in a clean, dry environment, protected from contamination, and following any specific maintenance or disinfection protocols to preserve its functionality and ensure hygiene between uses.
Does the Needle Remover come in multiple sizes or configurations, or is it available in a single design?
The Needle Remover is available in a single configuration, as referenced in the FDA 510(k) clearance (K881866). There are no variations in size or design specified in the available data, indicating it is intended for general use without customization.
Can the Needle Remover be used in an MRI environment, or are there any compatibility concerns?
The Needle Remover is explicitly noted as not MRI-compatible. This means it should not be used in or near MRI machines, as the device’s materials or design may interfere with MRI functionality or pose risks during imaging procedures.