Robertsite Stopcock
510(k) K061143
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061143 | Date10 May 2006 | 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- Withdrawn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
- FMG
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Robertsite Stopcock is a stopcock (product code FMG), a manual valve used to control the flow of fluids in medical applications. It features multi-directional flow capabilities and a needleless access port, enabling precise regulation of intravenous (IV) or vascular system fluid administration. Designed for general hospital use, it facilitates controlled transfer between connected components in fluid administration systems.
This device is supplied as a reusable medical instrument, intended for use in sterile environments such as operating rooms, intensive care units, or procedural suites. It is classified as a Class 2 device under FDA regulations and has received FDA 510(k) clearance via the Traditional pathway. No MRI safety or single-use specifications are noted; storage and handling must comply with standard medical device sterilisation protocols. The device’s regulatory filing (K061143) reflects its submission under the General Hospital category.
Other devices from Halkey-Roberts Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Robertsite Stopcock used for in medical settings?
The Robertsite Stopcock is a manual valve designed to control the flow of fluids in medical applications, such as intravenous (IV) or vascular system administration. Its multi-directional flow capabilities allow precise regulation of fluid transfer between connected components in fluid administration systems, making it ideal for use in sterile environments like operating rooms, intensive care units, or procedural suites.
Is the Robertsite Stopcock intended for single-use or reusable applications?
The Robertsite Stopcock is supplied as a reusable medical instrument. It is intended for repeated use in sterile environments, provided it adheres to standard medical device sterilization protocols. Reusability is a key feature for maintaining cost-effectiveness and reducing waste in hospital settings.
How should the Robertsite Stopcock be stored and handled?
The Robertsite Stopcock must be stored and handled in accordance with standard medical device sterilization protocols to ensure sterility and functionality. Since it is reusable, proper cleaning, disinfection, and sterilization between uses are critical to prevent contamination and maintain performance. Always follow manufacturer guidelines for sterilization methods.
Does the Robertsite Stopcock have any special compatibility or safety considerations?
The Robertsite Stopcock does not have specific MRI safety certifications mentioned in its documentation. It is designed for general hospital use and must be used in compliance with standard medical device handling practices. Ensure it is compatible with the materials and systems it connects to in your fluid administration setup.
What regulatory pathway was followed for the Robertsite Stopcock’s clearance?
The Robertsite Stopcock received FDA 510(k) clearance through the Traditional pathway, demonstrating substantial equivalence to a predicate device. It is classified as a Class 2 medical device under FDA regulations and was submitted under the General Hospital category (product code FMG). The filing number for this submission is K061143.