Search Results
Found 3 results
510(k) Data Aggregation
K Number
K020952Device Name
SURX RF SYSTEM
Manufacturer
SURX, INC.
Date Cleared
2002-05-30
(66 days)
Product Code
MUK
Regulation Number
878.4400Why did this record match?
Product Code :
MUK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SURx RF System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility.
Device Description
The SURx RF System consists of two components: the SURx Radiofrequency (RF) Generator and the SURx Applicator. The SURx Applicator connects to the Generator. The SURx Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, such that no return pad is required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area. Two applicators are available: one for use when performing this procedure using a laparoscopic approach (LP Applicator), the other applicator is used during a transvaginal approach (TV Applicator). The SURx Transvaginal (TV) Sizer is an optional accessory for use with the SURx TV Applicator. The SURx TV Sizer confirms the exposed area for treatment is adequate to Applicator. The SON blunt dissection is required prior to applying the SURx TV Applicator tip on the tissue to treated.
Ask a Question
K Number
K020126Device Name
MODIFICATION TO SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX TV SYSTEM)
Manufacturer
SURX, INC.
Date Cleared
2002-03-15
(59 days)
Product Code
MUK
Regulation Number
878.4400Why did this record match?
Product Code :
MUK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SURx TV System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.
Device Description
The SURx TV System consists of two components: the SURx TV Generator and the SURx TV Applicator. The SURx TV Applicator connects to the Generator. The Applicator also provides irrigation to the treatment site. The SURx TV Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, which means that a return pad is not required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area. The SURx TV Generator is a radiofrequency (RF) electronic instrument. Software is utilized in the operation of the SURx TV Generator.
Ask a Question
K Number
K011190Device Name
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP SYSTEM)
Manufacturer
SURX, INC.
Date Cleared
2002-01-08
(264 days)
Product Code
MUK, GEI
Regulation Number
878.4400Why did this record match?
Product Code :
MUK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SURx Laparoscopic Probe (LP) Radio Frequency (RF) System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.
Device Description
The SURx LP System consists of two components: the SURx LP Generator and the SURx LP Applicator. The SURx LP Applicator connects to the Generator. The Applicator also provides irrigation to the treatment site. The SURx LP Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, which means that a return pad is not required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area. The SURx LP Generator is a radiofrequency (RF) electronic instrument. Software is utilized in the operation of the SURx LP Generator.
Ask a Question
Page 1 of 1