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510(k) Data Aggregation
K Number
K232407Device Name
Cautery Protective Actuation System (CPAS)
Manufacturer
Date Cleared
2023-10-06
(57 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Safer Surgeries Medical Devices, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cautery Protective Actuation System (CPAS) is intended for use in general surgical procedures to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation. The CPAS device includes a safety cover intended to prevent inadvertent actuation of the monopolar electrocautery device, and to prevent secondary burns from a hot tip.
Device Description
The Cautery Protective Actuation System device is a sterile, single-use, monopolar electrocautery pen intended to deliver electrosurgical energy to the surgery site for tissue cutting and coagulation. The C-PAS device has a retractable cover, which functions to reduce the risk of inadvertent actuation that can result in burns, fires, patient impalement, or secondary contact from exposure to a hot tip. In the resting position, the cover guards both the tip and the rocker switch, and thereby prevents inadvertent actuation of the device. The "dead-man" trigger forces the user to squeeze the trigger in order to retract the safety cover and thereby access the rocker switch to actuate the monopolar electrocautery pen. The C-PAS device functions identically to a standard, monopolar electrocautery pen with the additional benefits of a retractable, protective shield.
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