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Found 6 results
510(k) Data Aggregation
K Number
K151976Device Name
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
Manufacturer
OMNITECH SYSTEMS, INC.
Date Cleared
2016-06-27
(347 days)
Product Code
FAS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
OMNITECH SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RESECTION ELECTRODES: The Omnitech HF Resection electrodes are a bipolar instrument series designed and intended for use in endoscopic urological surgical procedures involving the resection, ablation, or removal of soft tissue and where hemostasis is required. The specific urological indications in the prostate, bladder and bladder neck. The procedures for which the devices can be used are: Transurethral resection in saline (TURis). Transurethral prostatectomy, transurethral resection of the prostate (TURP), for benign prostatic hyperplasia, Transurethral incision of the prostate (TUIP) or bladder neck, Transurethral resection of bladder tumors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.
VAPORIZATION ELECTRODE: The Omnitech HF Vaporization electrode for plasma vaporization is a bipolar instrument designed and intended for use in urological surgical procedures involving vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue indications include: Use in the prostate, bladder, and bladder neck. The specific treatment indications include benign prostate hyperplasia (BPH), bladder cancer, tumors, lesions and neoplasms. The specific urological indications include Transurethral Electro vaporization (TUVP), (TVP), (TVP), (TVP), (TVP), (TUEVP) also known as Transurethral Vapor Resection of the prostate (TUVRP), Transurethral Vaporization in Saline (TUVis). These devices are intended to be used in an irrigated environment. These devices are not intended to be used in treating cancer of the prostate.
Device Description
Not Found
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K Number
K050454Device Name
OMNITECH FULGURATING ELECTRODE
Manufacturer
OMNITECH SYSTEMS, INC.
Date Cleared
2005-05-27
(94 days)
Product Code
FAS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
OMNITECH SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omnitech Fulgurating Electrode Device is indicated for the resection/coagulation of the soft tissue and is intended for the use with compatible Cystoscopes and Ureteroscopes. The device will be sold as a sterile product to be used in the Urological field.
Device Description
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K Number
K981463Device Name
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
Manufacturer
OMNITECH SYSTEMS, INC.
Date Cleared
1998-07-17
(85 days)
Product Code
KNF
Regulation Number
884.4160Why did this record match?
Applicant Name (Manufacturer) :
OMNITECH SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omnitech Resectoscope Roller Device is indicated for ablation/ coagulation of the soft tissue and is intended for the use with compatible resectoscopes. The device will be sold as a sterile product to be used in the Urological and Gynecological fields.
Device Description
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K Number
K981464Device Name
OMNITECH RESECTOSCOPE CUTTING LOOP ELECTRODE
Manufacturer
OMNITECH SYSTEMS, INC.
Date Cleared
1998-07-10
(78 days)
Product Code
KNF
Regulation Number
884.4160Why did this record match?
Applicant Name (Manufacturer) :
OMNITECH SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Omnitech Resectoscope Cutting Loop Electrode Device is indicated for resection/ coagulation of the soft tissue and is intended for the use with compatible resection/ The device will be sold as a sterile product to be used in the Urological and Gynecological fields.
Device Description
Omnitech Resectoscope Cutting Loop Electrode
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K Number
K964365Device Name
RESECTOSCOPE CUTTING LOOP ELECTRODE
Manufacturer
OMNITECH SYSTEMS, INC.
Date Cleared
1997-04-22
(172 days)
Product Code
FAS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
OMNITECH SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K965093Device Name
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
Manufacturer
OMNITECH SYSTEMS, INC.
Date Cleared
1997-03-19
(90 days)
Product Code
FAS
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
OMNITECH SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
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