Irrigation Tray with Piston Syringe

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K942221 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

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See all devices from Trinity Laboratories, Inc. →

• What types of medical procedures is this irrigation tray with piston syringe designed to assist with, and where is it typically used?

  This device is designed as a surgical irrigation system for controlled fluid delivery during medical procedures. It is specifically intended for use in hospital settings and is part of a sterile, single-use kit. The piston syringe allows for precise irrigation pressure, making it suitable for procedures requiring careful fluid management, such as wound irrigation, joint lavage, or other surgical applications where irrigation is critical.

• Is this irrigation tray reusable, or is it meant for single-use only? How does that affect its sterility?

  The device is explicitly supplied as a sterile, single-use kit. This means it is intended for one-time use only to maintain sterility and reduce the risk of contamination or infection. Reusing it would violate the manufacturer’s design intent and could compromise patient safety.

• What does the product code FMF indicate about this device’s regulatory classification, and how does it relate to its use?

  The product code FMF classifies this device under the FDA’s surgical irrigation systems category. This classification aligns with its intended use as a surgical tool for controlled fluid delivery during procedures, distinguishing it from non-surgical irrigation tools. The FMF code helps regulators and healthcare providers identify its purpose and applicable safety standards.

• How is this irrigation tray with piston syringe different from standard irrigation systems, and what advantages does the piston mechanism provide?

  Unlike traditional irrigation systems that may rely on gravity or manual pumping, this device incorporates a piston-driven syringe, allowing clinicians to precisely control irrigation pressure. This feature is particularly useful in procedures where consistent fluid flow is critical, such as joint lavage or delicate tissue irrigation, as it reduces the risk of over- or under-pressurization that could damage tissue or compromise sterility.

• What should I consider when storing this irrigation tray, and are there any specific handling instructions?

  Since this is a sterile, single-use kit, it should be stored in its original packaging until ready for use to preserve sterility. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Once opened, the device must not be reused, and any unused portions should be discarded according to medical waste protocols to prevent contamination.