FDA Clears First 1000mL System for Wound Irrigation

It lets clinicians to mechanically loosen and remove debris and microorganism from wounds.

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BD

BD announced it received 510(k) clearance from the FDA for the Surgiphor 1000mL. As the first and only 1000 mL antimicrobial irrigation system specifically designed for powered lavage, Surgiphor 1000mL provides a standardized, OR-ready solution that enhances surgical safety and efficacy.

This latest addition to the Surgiphor portfolio allows clinicians to mechanically loosen and remove debris and microorganism from wounds within powered irrigation workflows. 

Surgiphor 1000mL arrives ready-to-use and completely sterile, eliminating the need for hospital staff to mix solutions by hand. This saves valuable time in the operating room while helping hospitals meet global safety guidelines for surgical wound cleaning. 

"This FDA clearance reinforces BD's position as the global leader in surgical irrigation innovation," said Rian Seger, worldwide president of the BD Surgery business. "Surgiphor 1000mL is a unique solution that provides the consistency and safety surgical teams expect from BD, allowing them to focus on what matters most: providing better, safer care for their patients."

Building on the adoption of the original Surgiphor system, the Surgiphor 1000mL configuration gives operating room teams a larger-volume option engineered to fit seamlessly into existing powered irrigation setups.

Key features of Surgiphor 1000mL:

  • Designed for powered irrigation: Compatible with many commonly used powered lavage devices, allowing quick integration into current OR practice.
  • Versatile interchangeability: Includes a powered-device adapter, Y-connector for simple switching between saline and Surgiphor solution, and a twist cap for manual use when needed.
  • Optimized flow and ergonomics: Integrated venting promotes smooth, unrestricted flow, while a collapsible bottle supports efficient evacuation and handling.
  • Terminally sterile PVP‑I solution: Part of the only surgical irrigation portfolio that provides terminally sterile PVP-I solutions in multiple sizes and delivery formats.
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