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510(k) Data Aggregation
K Number
K191583Device Name
PhotonBlade with Smoke Evacuation
Manufacturer
Invuity Inc.
Date Cleared
2020-03-06
(266 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Invuity Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PhotonBlade® with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.
Device Description
The PhotonBlade® with Adaptive Smoke Evacuation (PB2SE) is a single use, sterile, electrosurgical device with a light and adaptive smoke evacuation attachment. The device has a monopolar electrode at the distal tip, which delivers Radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode tip is located at the distal end of a rotatable and extendable shaft. The adaptive smoke evacuation attachment connects to the telescoping shaft and the cable of the PhotonBlade. It incorporates a barb connector at the end of the tubing to allow connection to a secondary suction hose connected to a smoke evacuation system. The device handle is integrated with controls for cut, coagulation, and illumination (light). A universal cable attaches the device to a 510(k) cleared electrosurgical unit.
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K Number
K162053Device Name
PhotonBlade
Manufacturer
Invuity Inc.
Date Cleared
2016-09-15
(52 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Invuity Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PhotonBlade is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures.
Device Description
The PhotonBlade is a single use, sterile, electrosurgical device with a light. The PhotonBlade has an electrode at the distal tip, which delivers RF energy for cutting and coagulation of soft tissue. The electrode tip is located at the distal end of a rotatable and extendable shaft. The device handle is integrated with controls for cut, coagulation, and illumination (light). A universal cable attaches the device to a 510(k) cleared electrosurgical unit.
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