Disposable Needle, Aspiration and Injection (K893233)
510(k) K893233
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893233 | Date4 Jan 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Disposable Needle, Aspiration and Injection
- 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
Overview
AI-generated summary, 1 Oct 2026
This device is a disposable needle for aspiration and injection, classified under FDA product code FMF. It is designed for single-use procedures requiring fluid withdrawal or administration, commonly used in general hospital settings. The needle is intended for percutaneous access to veins, arteries, or subcutaneous tissues, ensuring minimal risk of contamination or cross-infection due to its disposable nature. Its construction adheres to standards for sterile medical instruments, preventing reuse and reducing infection transmission.
The Disposable Needle, Aspiration and Injection (K893233) is supplied as a sterile, single-use device and must not be reused after one application. It is regulated under FDA 510(k) clearance (K893233) with a Traditional clearance type, classified as FDA Class II. No specific MRI safety information is provided, and storage conditions are not detailed in the regulatory submission. The device is intended for use in general hospital environments, with no additional clinical indications or restrictions stated beyond its labeled purpose.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of the Pioneer K893233 disposable needle?
The Pioneer K893233 disposable needle is designed for single-use procedures involving fluid withdrawal (aspiration) or administration (injection). It is intended for percutaneous access to veins, arteries, or subcutaneous tissues in general hospital settings. Its disposable nature ensures minimal risk of contamination or cross-infection, making it suitable for procedures where sterility is critical.
How is the Pioneer K893233 needle supplied and should it be reused?
The needle is supplied as a sterile, single-use device and must never be reused after one application. The design and regulatory classification (FDA 510(k) clearance) explicitly prohibit reuse to prevent infection transmission and maintain sterility standards for medical instruments.
What regulatory approval does the Pioneer K893233 needle hold?
The device holds FDA 510(k) clearance under the reference number K893233, classified as substantially equivalent (SESE) and granted a Traditional clearance type. It is categorized under FDA product code FMF, intended for general hospital use without additional clinical restrictions.
Are there any special storage instructions for this needle?
The regulatory submission does not specify storage conditions for the Pioneer K893233 needle. Clinicians should follow general guidelines for sterile single-use medical devices, such as keeping it in a sealed, dry environment away from direct sunlight or extreme temperatures until use.
Is this needle safe for use with MRI procedures?
The regulatory documentation for the Pioneer K893233 needle does not provide any information regarding its MRI safety. Clinicians should verify compatibility with MRI equipment and protocols before use in an MRI environment.