Worldwide Medical Technologies Bone Marrow Biopsy Needle

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

510(k) Number

K974794 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Worldwide Medical Technologies, LLC →

• What is the Worldwide Medical Technologies Bone Marrow Biopsy Needle used for?

  This needle is specifically designed for percutaneous puncture to obtain bone marrow samples, primarily from the posterior iliac crest of the pelvis. It aids clinicians in collecting tissue for histopathological examination, which is essential for diagnosing various hematological conditions.

• Is the bone marrow biopsy needle reusable or single-use?

  The Worldwide Medical Technologies Bone Marrow Biopsy Needle is supplied as a reusable surgical instrument. It is intended for use in clinical settings like hospitals or diagnostic centers, where standard aseptic techniques for surgical instruments must be followed to ensure safety and sterility between uses.

• What regulatory clearance does this device have?

  The device is regulated under FDA 510(k) clearance with the reference number K974794. It is classified as a Class II device under Special Controls and was determined to be substantially equivalent to a predicate device by the FDA.

• Does the manufacturer provide information on sterility or MRI safety?

  The available data does not specify any details regarding sterility or MRI safety for the Worldwide Medical Technologies Bone Marrow Biopsy Needle. Clinicians should adhere to standard aseptic techniques for surgical instruments during use.

• What types of clinical settings is this needle intended for?

  This needle is intended for use in clinical settings such as hospitals and diagnostic centers where bone marrow biopsy procedures are performed. Its design supports diagnostic procedures requiring precise tissue sampling for histopathological analysis.