4-WAY Stopcock W/100 Cm Tubing, Luer-Lk

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K760678 ↗

FDA Product Code

FMG

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Needle, Membrane

  Class II

  FDA 510(k) K770528 Active Cleared 29 Apr 1977

• I.V. Catheter Placement Unit

  Class II

  FDA 510(k) K770181 Active Cleared 30 Mar 1977

• Epidural Block Procedure Pack

  Class II

  FDA 510(k) K770096 Active Cleared 25 Feb 1977

• 4-Way Stopcock W/7cm Tubing,

  Class II

  FDA 510(k) K760679 Active Cleared 2 Dec 1976

• 4-Way Stopcock W/10 Cm Exten. Tubing

  Class II

  FDA 510(k) K760667 Active Cleared 2 Dec 1976

• 4-Way Stopcock W/Luer-Lock Fitting

  Class II

  FDA 510(k) K760666 Active Cleared 2 Dec 1976

See all devices from American Viggo →

• What is the 4-Way Stopcock W/100 Cm Tubing used for?

  This device is designed for multi-directional fluid control in hospital settings. It features a polycarbonate body with a polyethylene handle and 100 cm of tubing for various medical applications in general hospital use.

• Is the 4-Way Stopcock W/100 Cm Tubing reusable or single-use?

  The device is supplied as a single-use item and is not intended for reuse. This design ensures sterility and prevents cross-contamination between patients.

• What is the regulatory classification of this device?

  The 4-Way Stopcock W/100 Cm Tubing is regulated under FDA 510(k) clearance with product code FMG and is classified as a Class II medical device. It has been determined to be substantially equivalent to predicate devices.

• Are there any special storage requirements for this device?

  The device requires appropriate storage conditions as specified by the manufacturer. While specific storage details aren't provided in the data, medical devices of this type typically should be stored in a clean, dry environment away from extreme temperatures.