Disposable 1CC Syringe with Luer Lock
by Interventional Therapeutics Corp.
510(k) K945588
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945588 | Date10 Feb 1995 | 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- Withdrawn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
- 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 syringe classified under product code FMF, designed for single-use administration or aspiration of fluids. The 1cc capacity and Luer Lock connector ensure secure attachment to compatible needles or tubing, reducing the risk of accidental disconnection. It is intended for general medical, laboratory, or veterinary use where precise fluid measurement and transfer are required.
The syringe is supplied as a sterile, single-use item, individually packaged to maintain sterility until first use. It complies with FDA 510(k) clearance (K945588) under the Traditional review pathway, classified as substantially equivalent to predicate devices. No MRI safety information is specified, and it is intended for use in clinical or procedural settings where aseptic technique is mandatory. Storage should follow manufacturer guidelines to preserve sterility and functionality.
Other devices from Interventional Therapeutics Corp.
Questions
AI-generated answers, 1 Oct 2026
What is the 1cc Luer Lock syringe designed for?
This disposable 1cc syringe with Luer Lock is intended for single-use administration or aspiration of fluids in clinical, laboratory, or veterinary settings. Its precise 1cc capacity and secure Luer Lock connector make it ideal for tasks requiring accurate fluid measurement and transfer, such as injections, sample collection, or irrigation procedures.
How is the syringe supplied and what does sterility mean for its use?
The syringe is supplied as a sterile, single-use item in individually packaged form to maintain sterility until first use. Sterility ensures it is free from harmful microorganisms, which is critical for medical procedures where aseptic technique is mandatory to prevent infection or contamination.
Is this syringe reusable or meant for single-use only?
This syringe is explicitly designed for single-use only. After use, it should be discarded to avoid cross-contamination and maintain compliance with infection control protocols. Reuse could compromise sterility and integrity, posing risks to patient safety.
What storage instructions should be followed to preserve its functionality?
The syringe should be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Typically, this means keeping it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.
Does this syringe have any special compatibility requirements with needles or tubing?
The Luer Lock connector on this syringe is designed for secure attachment to compatible needles or tubing, reducing the risk of accidental disconnection during use. Ensure the needle or tubing you attach has a matching Luer Lock fitting to maintain a tight seal and prevent leaks.