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510(k) Data Aggregation
K Number
K202071Device Name
SURGIPHOR Wound Irrigation System
Manufacturer
Orthophor, LLC
Date Cleared
2020-10-23
(88 days)
Product Code
FQH, FOH
Regulation Number
880.5475Why did this record match?
Applicant Name (Manufacturer) :
Orthophor, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SURGIPHOR™ Wound Irrigation System is a wound cleansing delivery system intended to loosen and remove wound debris.
Device Description
SURGIPHOR™ Wound Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of SURGIPHOR™ (0.5% Povidone lodine) solution which is used first to loosen wound debris, and one bottle of SurgiRinse™ solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris from wounds. The SURGIPHOR™ Wound Irrigation System is provided as a two part terminally sterilized system with 475 mL of each solution. The povidone iodine in the SURGIPHOR™ solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.
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