VACO Suction Electrode Unit

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

510(k) Number

K860758 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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• What is the VACO Suction Electrode Unit used for?

  The VACO Suction Electrode Unit is used in physical medicine applications, combining suction and electrode functionality for therapeutic or diagnostic purposes in clinical settings.

• Is the VACO Suction Electrode Unit reusable or single-use?

  The VACO Suction Electrode Unit is supplied as a reusable unit, meaning it is designed for multiple uses after appropriate cleaning and reprocessing in accordance with manufacturer instructions.

• What regulatory pathway was used for the VACO Suction Electrode Unit?

  The VACO Suction Electrode Unit received FDA 510(k) clearance, demonstrating substantial equivalence to a legally marketed predicate device under product code IPF and decision code SESE.