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The BioSurgical Corp. Multi Chamber Suction Syringe is indicated for the mixing and application of FDA approved fluids to wounds, the delivery of antibiotics, and other wound treatment fluids. It can also be attached to standard hospital wall suction for removal of fluid debris, excess tissue or foreign particles in the wound.

Multi Chamber Suction Syringe

This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance results, sample sizes, expert qualifications, adjudication methods, details of comparative effectiveness studies, or ground truth establishment.

The letter focuses on:

• Device: BioSurgical Corporation Multi Chamber Suction Syringe (K964597)
• Regulatory Decision: Substantially equivalent to pre-amendment devices, allowing it to be marketed.
• Indications for Use: Mixing and applying FDA-approved fluids to wounds, delivering antibiotics and other wound treatment fluids, and attachment to hospital wall suction for removal of fluid debris, excess tissue, or foreign particles in the wound.

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