BD Surgiphor Antimicrobial Irrigation System

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K221504 ↗

FDA Product Code

FQH

Device Class

Class II

Regulation

21 CFR Part 880.5475

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What is the BD Surgiphor Antimicrobial Irrigation System used for?

  The BD Surgiphor Antimicrobial Irrigation System is a ready-to-use aqueous PVP-I lavage solution used to mechanically loosen and remove debris and foreign materials, including microorganisms from wounds. It provides a broad-spectrum antimicrobial effect against gram-positive and gram-negative bacteria and yeast.

• How is the BD Surgiphor Antimicrobial Irrigation System supplied?

  The system is supplied as a sterile solution in a 450mL size. It has a validated sterility assurance level of 10-6, the same level required for injectable products and implantable devices, ensuring high sterility standards for wound care.

• Is the BD Surgiphor Antimicrobial Irrigation System reusable or single-use?

  The BD Surgiphor Antimicrobial Irrigation System is designed for single-use applications. It is supplied as a sterile solution and should not be reused to maintain sterility and prevent potential contamination of wounds.

• What regulatory approvals does the BD Surgiphor Antimicrobial Irrigation System have?

  The BD Surgiphor Antimicrobial Irrigation System is FDA 510(k) cleared with product code FQH. It is intended for use in general hospital settings and has been determined to be substantially equivalent to predicate devices in this category.