Irrigation Tray W/ Piston Syringe & Sterile Water

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

510(k) Number

K923938 ↗

FDA Product Code

EYN

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SEKD

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See all devices from American Healthcare, Inc. →

• What medical specialties is this irrigation tray designed for?

  This irrigation tray is specifically designed for use in gastroenterology and urology procedures. It is intended to assist in cleaning or flushing body cavities, wounds, or surgical sites where controlled irrigation is required. The device’s construction aligns with sterile field requirements, making it suitable for clinical settings like operating rooms or procedural suites.

• Is this irrigation tray reusable or single-use?

  This irrigation tray is a sterile, single-use device. It is intended for one-time clinical use only, ensuring patient safety and sterility. After use, the tray should be disposed of properly to prevent contamination or reuse.

• What components does the irrigation tray include?

  The irrigation tray includes a piston syringe for controlled fluid administration and a sterile water reservoir. It does not come with additional components like saline or gauze, as specified by the manufacturer. The combination of these elements allows for precise irrigation during medical procedures.

• How should this irrigation tray be stored?

  The irrigation tray must be stored while maintaining the integrity of its sterile packaging. This ensures that the device remains uncontaminated and ready for use in clinical settings. Always follow manufacturer guidelines for storage to preserve sterility and functionality.

• Does this device have any special considerations for use in imaging environments?

  No MRI safety considerations are indicated for this irrigation tray. It is designed for use in standard clinical environments, including operating rooms and procedural suites, without any restrictions related to magnetic resonance imaging.