Three-Way Stopcock Extension Set 20-SL
by Abbott Laboratories 510(k)
Active
510(k) K800284
Overview
This device is a three-way stopcock extension set, classified as an intravenous (I.V.) set with a stopcock mechanism. It is designed to control the flow of fluids between three connected pathways, enabling precise administration or diversion of intravenous solutions, medications, or fluids in clinical settings. The stopcock allows for selective opening or closing of channels, ensuring controlled fluid transfer while minimizing contamination risk.
The Three-Way Stopcock Extension Set 20-SL is intended for single-use in hospital environments, as categorized under the General Hospital medical specialty. It is supplied sterile and falls under FDA Class II regulatory classification, with a Traditional 510(k) clearance (K800284) granted in 1980. The device adheres to regulation 880.5440 and is distributed under product code FMG. No MRI safety or reusable specifications are noted.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800284 | Date26 Feb 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Abbott Laboratories
Questions
What is the Abbott Three-Way Stopcock Extension Set 20-SL used for?
The Abbott Three-Way Stopcock Extension Set 20-SL is designed to control and direct the flow of intravenous fluids, medications, or solutions between three connected pathways in clinical settings. Its stopcock mechanism allows healthcare providers to selectively open or close channels, ensuring precise administration or diversion of fluids while minimizing contamination risks during procedures like transfusions, blood draws, or medication delivery.
Is the Three-Way Stopcock Extension Set 20-SL sterile and single-use?
Yes, the Three-Way Stopcock Extension Set 20-SL is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination between patients or procedures, as reuse could introduce pathogens or compromise sterility.
How is the Three-Way Stopcock Extension Set 20-SL supplied, and what are its regulatory details?
The device is supplied as a sterile, single-use extension set packaged for immediate clinical use. It holds an FDA Traditional 510(k) clearance (K800284) under regulation 880.5440, classified as a Class II medical device for general hospital use. The clearance was granted in 1980 and remains valid for controlled fluid administration in approved settings.
Can this stopcock be used with MRI equipment, or is it reusable?
The Three-Way Stopcock Extension Set 20-SL is not specified for MRI compatibility, so its use in MRI environments should be evaluated based on clinical protocols and facility guidelines. Additionally, it is explicitly designed for single-use only, meaning it must not be reused or reprocessed to maintain safety and sterility standards.
What sizes or models are available for the Three-Way Stopcock Extension Set?
The device data provided does not specify individual sizes or additional model variants beyond the 20-SL reference. However, the product code FMG and regulatory filings indicate it is part of a broader family of stopcock extension sets. For exact sizing or alternative models, consult Abbott Laboratories’ product catalog or technical documentation, as variations may exist for specific clinical needs.