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510(k) Data Aggregation
K Number
K060076Device Name
SURGICOUNT SAFETY-SPONGE SYSTEM
Manufacturer
SURGICOUNT MEDICAL
Date Cleared
2006-03-14
(63 days)
Product Code
LWH
Regulation Number
880.2740Why did this record match?
Applicant Name (Manufacturer) :
SURGICOUNT MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SurgiCount Medical Safety-Sponge System™ is indicated for use in counting and recording the number of thermally labeled surgical sponges, laparotomy sponges and towels used during surgical procedure.
Device Description
The Safety Sponges include surgical sponges, laparatomy pads and surgical towels, each unit of which contains a unique identification label permanently fused to the gauze or fabric. The labels allow the sponges and towels to be individually recognized by a commercially available sight laser imager.
The Safety Sponge Counter is a commercially available mobile computer with specialized software designed for mobile data collection. Integrated imaging technology allows capture of the information coded in the unique identification label on the sponges, pads and towels. The computer counts the initial number of sponges opened, and using the custom software program, reports the total sponges used at the end of the procedure or on demand, and compares that number to the original. Individual sponges may be identified as entered into the surgical field but not discarded, so that the surgical field can be explored before surgically closing the patient.
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