BD earns FDA 510(k) clearance for Surgiphor 1000mL system

BD (NYSE: BDX) + received FDA 510(k) clearance for its Surgiphor 1000mL antimicrobial irrigation system, the company announced today.

The Surgiphor 1000mL system mechanically irrigates debris and microorganisms from wounds by delivering a ready-to-use, terminally sterile povidone-iodine lavage. Following its FDA clearance, Surgiphor 1000mL expands BD’s Surgiphor portfolio and offers surgical teams a larger volume option 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.”

Surgiphor 1000mL’s compatibility with commonly used power lavage devices allows for quick integration into established operating room workflow. It includes a powered-device adapter, Y-connector for transitions between saline and the Surgiphor solution, and a twist cap for manual use when needed.

Surgiphor was designed to reduce variability by providing a consistent concentration of the solution and eliminate the need for operating room staff time to mix solutions by hand; saving staff valuable time, mitigating contamination risks while meeting safety guidelines.

BD’s Surgiphor now expanded portfolio offers both manual and powered irrigation configurations, giving surgical teams more flexibility to match the needs of their workflow and patient population.