Worldwide Medical Technologies Bone Marrow Biopsy Procedure Tray

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

510(k) Number

K980137 ↗

FDA Product Code

LRO

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• Is this tray intended for reuse or is it meant to be used only once per procedure?

  This Bone Marrow Biopsy Procedure Tray is explicitly designed for single-use only. The manufacturer specifies it as a non-sterile procedural kit, meaning it should not be reused after a single procedure to maintain sterility and procedural integrity. Reuse could compromise patient safety and regulatory compliance.

• What clinical settings is this tray approved for use in, and how should it be stored?

  The tray is approved for use in clinical settings such as hospitals or outpatient surgical centers. Since it is non-sterile, storage and handling must follow standard aseptic practices to ensure procedural integrity. This includes keeping it in a clean, dry environment away from direct contamination until ready for use.

• How do I know if this tray is compatible with my facility’s bone marrow biopsy procedures?

  This tray is intended to organize and house the necessary instruments and supplies required for a bone marrow biopsy procedure, ensuring procedural efficiency. While it is not a diagnostic or therapeutic device itself, its design aligns with standard biopsy workflows. Verify compatibility by confirming that your facility’s existing biopsy protocols and equipment can integrate with the included tools—such as biopsy needles, syringes, and collection containers—without modification.

• What does the FDA’s classification under the General, Plastic Surgery category mean for this product?

  The FDA’s classification under the General, Plastic Surgery category (Product Code: LRO) indicates this tray falls under Class II regulatory requirements, meaning it is subject to special controls to ensure its safety and effectiveness. While it does not perform surgical procedures itself, the tray’s design and contents must meet FDA standards for procedural organization and sterility. The 510(k) clearance (K980137) confirms it is deemed substantially equivalent to a legally marketed device, ensuring compliance with FDA guidelines.