Platypus AV Fistula Needle Protector (AVFNP)

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

510(k) Number

K991404 ↗

FDA Product Code

FMI

Device Class

Class II

Regulation

21 CFR Part 880.5570

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Samplok

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  FDA 510(k) K021941 Active Cleared 2 Jul 2002

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• What clinical procedures is the Platypus AVFNP designed for?

  It is intended for use after hemodialysis and apheresis procedures. By covering the needle once the treatment is finished, it reduces the chance of a clinician or patient receiving an accidental needle stick, which is a common source of biohazard exposure in these settings.

• Is the Platypus AVFNP reusable or single‑use?

  The device is supplied as a single‑use item and is not intended for reuse. Single‑use design ensures that each needle protection event uses a sterile, uncontaminated protector, eliminating the risk of cross‑contamination between patients.

• How is sterility maintained for the Platypus AVFNP?

  The protector is packaged sterile and remains sealed until the point of use. Because it is discarded after one procedure, the sterility of the device is preserved throughout its intended use, providing a reliable barrier against bloodborne pathogens.

• Can the Platypus AVFNP be used in an MRI environment?

  No, the device is not marked for MRI safety. It should not be introduced into the magnetic field of an MRI scanner, as its materials have not been evaluated for compatibility and could pose a safety risk.

• What regulatory clearance does the Platypus AVFNP have?

  The Platypus AVFNP received FDA 510(k) clearance (K991404) and is classified as substantially equivalent to a predicate device. This clearance indicates that the FDA has reviewed the device’s safety and effectiveness for its intended use.