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510(k) Data Aggregation
K Number
K222695Device Name
troCarWash System
Manufacturer
Biotex Inc.
Date Cleared
2023-02-17
(164 days)
Product Code
OCX, FEQ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Biotex Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The troCarWash™ system consists of a reusable control unit and a disposable, sterile, single-use trocar intended to remove visual obstructions such as condensation, blood, and other tissue particulates from the distal lens of a laparoscope during surgery and therefore maintain a clear image of the surgical site.
Device Description
The troCarWash™ system is a laparoscopic lens cleaning device which is intended to be used during any laparoscopic surgical procedure where there is a potential for contamination of the laparoscope. Consisting of a mains powered reusable control unit, and a single use disposable trocar, obturator, and tubing set, it is intended to maintain surgical vision by removing contaminants such as condensation, blood, peritoneal fluid, smoke, fat, and tissue smears that have contaminated the distal lens of the laparoscope during surgical procedures providing a clear image of the The disposable portion of the system is sterilized via irradiation and has limited (<24 hours) patient contact with abdominal tissue. The trocar and obturator are primarily made of ABS and polycarbonate, and the tubing set is made of ABS, Polycarbonate, and PVC tubing. The system is intended for use in typical hospital environments by medical professionals and is suitable for all patients approved for laparoscopic operations. The system incorporates a software that initiates a short (<250 millisecond) wash and dry mechanism to efficiently clean the laparoscope and may be initiated with a natural single-handed surgical motion of retracting the scope momentarily into the supplied trocar.
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