Procedur 10 Syringe Device
by Avanca Medical Devices, Inc.
510(k) K042486
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042486 | Date21 Jan 2005 | 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- Withdrawn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, 20 Sep 2026
The Procedur 10 Syringe Device is a piston syringe device (FDA Product Code: FMF) designed to facilitate precise fluid injection or withdrawal from the body. It combines two syringe components within a plastic holder, with plungers linked by a pulley mechanism to enable coordinated control. This configuration allows clinicians to operate both syringes simultaneously, improving efficiency and accuracy during procedures. The device is classified under the General Hospital category and is intended for use in medical settings requiring dual-syringe manipulation.
The Procedur 10 Syringe Device is supplied as a single-use medical instrument, as implied by its regulatory submission and intended clinical application. It is not specified as MRI-safe or sterile in the provided data, though standard sterile packaging would be expected for medical syringe devices. The device is regulated under FDA 510(k) clearance (K042486), with a decision date of January 21, 2005, and is intended for use in procedures requiring dual-syringe coordination, such as contrast media administration or fluid exchange. Storage and handling should comply with general medical device guidelines for syringe devices.
Other devices from Avanca Medical Devices, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical procedures is the Procedur 10 Syringe Device specifically designed to improve, and how does its dual-syringe mechanism help?
The Procedur 10 Syringe Device is designed to improve efficiency and accuracy during procedures requiring coordinated fluid injection or withdrawal, such as contrast media administration or fluid exchange. Its dual-syringe mechanism—where two syringes are linked via a pulley system—allows clinicians to operate both simultaneously, ensuring precise control and synchronization of fluid movement.
Is the Procedur 10 Syringe Device intended for reuse, or is it meant to be used only once?
The Procedur 10 Syringe Device is explicitly intended for single-use, as implied by its regulatory submission and typical clinical application for medical syringe devices. Single-use design minimizes contamination risks and ensures patient safety.
How should the Procedur 10 Syringe Device be stored, and are there any special handling instructions?
While specific storage instructions aren’t detailed in the provided data, standard medical device guidelines for syringe devices should be followed. This typically includes keeping the device in a clean, dry environment, protected from direct sunlight or extreme temperatures, and adhering to manufacturer recommendations if additional packaging or instructions are included.
What regulatory pathway was followed for FDA clearance of the Procedur 10 Syringe Device, and when was it approved?
The Procedur 10 Syringe Device received FDA clearance through a 510(k) submission (K042486), classified as *Substantially Equivalent* under the Traditional review pathway. The decision was made by the General Hospital (HO) Advisory Committee and granted on January 21, 2005, following receipt of the application on September 13, 2004.