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510(k) Data Aggregation
K Number
K103775Device Name
PEAK SUCTION COAGULATOR
Manufacturer
PEAK SURGICAL, INC.
Date Cleared
2011-05-27
(151 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PEAK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suction Coagulator is a single use electrode attachment, designed to be attached to the PEAK PlasmaBlade TnA handpiece and is intended for use in surgical procedures, such as general and otolaryngology (ENT) surgery procedures, where the coagulation of tissue and suction of fluids are desired. It is not indicated for the removal of tonsils and adenoids.
Device Description
The PEAK Suction Coagulator consists of of an active suction lumen, a bendable shaft, and a finger grip for attachment to the TnA handpiece and is to be used for the coagulation of tissues and aspiration of fluids during electrosurgical procedures. The device is activated by pressing the coag button (blue) on the TnA handpiece.
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K Number
K102709Device Name
PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE
Manufacturer
PEAK SURGICAL, INC.
Date Cleared
2010-12-17
(88 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PEAK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PEAK PlasmaBlade® PLUS Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
Device Description
The PEAK PlasmaBlade® PLUS consists of a single insulated bendable blade, telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip incorporates a suction lumen for the evacuation of smoke and fluids. A ball electrode attaches to the finger grip to allow a broader application of energy. The PlasmaBlade PLUS is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, PlasmaBlade EXT and PlasmaBlade 3.0S.
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K Number
K102029Device Name
PEAK PULSAR II GENERATOR MODEL PS100-102
Manufacturer
PEAK SURGICAL, INC.
Date Cleared
2010-12-16
(150 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PEAK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
Device Description
The PEAK Surgery System consists of the PULSAR II Generator, PEAK PlasmaBlade Tissue Dissection Devices and an optional wireless footswitch. The PULSAR II Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar RF energy for cutting and coagulation during surgery. The PULSAR II Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices which are single use, sterile handpieces for monopolar energy delivery. The PlasmaBlade Tissue Dissection Devices consist of an insulated blade electrode, rotating shaft, handle with integrated controls and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpieces.
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K Number
K093695Device Name
PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
Manufacturer
PEAK SURGICAL, INC.
Date Cleared
2010-04-13
(134 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PEAK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PEAK PlasmaBlade® 3.0S Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
Device Description
The PEAK PlasmaBlade® 3.0S consists of a single insulated bendable blade. telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids. The PlasmaBlade 3.0S is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, and PlasmaBlade EXT.
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K Number
K083415Device Name
PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE
Manufacturer
PEAK SURGICAL, INC.
Date Cleared
2009-06-05
(199 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PEAK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PEAK PlasmaBlade™ TnA Tonsil and Adenoid Tissue Dissection Device is only indicated for cutting and coagulation of soft tissue during otolaryngology (ENT) surgery including adenoidectomy and tonsillectomy (Pharyngeal, Tubal, Palatine).
Device Description
The PEAK PlasmaBlade TnA Tonsil and Adenoid Tissue Dissection Device consists of a handpiece with integrated controls and cable, a shaft with a suction cannula, and two interchangeable tips. The tonsil tip consists of a curved and tapered insulated blade electrode with an opening in the center to allow for the evacuation of smoke and fluids. The adenoid tip consists of a flat, straight insulated blade electrode housed in a plastic tip with a bendable suction lumen that allows for the evacuation of tissue, fluids and smoke. Both tips connect to the suction cannula of the handpiece.
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K Number
K082786Device Name
PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES
Manufacturer
PEAK SURGICAL, INC.
Date Cleared
2008-12-03
(71 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PEAK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PEAK Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
Device Description
The PEAK Surgery System consists of the PULSAR Generator, PEAK PlasmaBlade Tissue Dissection Devices, and an optional wireless foot pedal. The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Devices, which are single use, sterile handpieces for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Devices consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpieces.
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K Number
K073057Device Name
PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040
Manufacturer
PEAK SURGICAL, INC.
Date Cleared
2008-07-22
(266 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
PEAK SURGICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PULSAR Generator with the PEAK PlasmaBlade Tissue Dissection Device is intended to be used for cutting and coagulation of soft tissue during surgical procedures.
Device Description
The PULSAR Generator is a microcontroller based, isolated output, electrosurgical unit that has been designed to produce monopolar and bipolar RF energy for cutting and coagulation during surgery. The PULSAR Generator is used with the PEAK PlasmaBlade Tissue Dissection Device, which is a single use, sterile handpiece for monopolar energy delivery. The PEAK PlasmaBlade Tissue Dissection Device consists of an insulated blade electrode, rotating bendable shaft, handle with integrated controls, and a cable. An optional footswitch may be used to operate the system in lieu of the controls on the PlasmaBlade handpiece.
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