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510(k) Data Aggregation
K Number
K153055Device Name
ACE Electrosurgical Resection and Vaporization Electrodes Series
Manufacturer
Date Cleared
2016-07-11
(265 days)
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Ace Medical Devices Pvt. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ACE Electrosurgical Resection and Vaporization Electrodes Series is a single use bipolar electrode series designed and intended for use in endoscopic urological procedures involving the resection, ablation or removal of soft tissue and coagulation where hemostasis is required. The specific urological indications include use in the prostate, bladder and bladder neck. The procedures for which the devices can be used are transurethral resection in saline (TURis). transurethral prostatectomy (TURP), transurethral resection of the prostate (TURP) for benign prostatic hyperplasia, transurethral incision of the prostate (TUIP) or bladder neck, transurethral resection of bladder turnors (TURBT) and cystodiathermy. These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used to treat cancer of the prostate.
The ACE Electrosurgical Resection and Vaporization Electrode Series are single use bipolar electrodes designed and intended for use in urological surgical procedures involving the vaporization, cutting, removal of soft tissue and coagulation where hemostasis is required. The specific soft tissue 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, TUEVP), also known as transurethral vapor resection of the prostate (TUVRP) or transurethral vaporization in saline (TUVis). These devices are intended to be used in an irrigated environment (0.9% Sodium Chloride). These devices are not intended to be used in treating cancer of the prostate.
Device Description
The ACE Electrosurgical Resection and Vaporization Electrodes Series consist of an active tip, PTFE color code identification, and an insulator between the electrode tube, a guiding tube, telescope clip and arm (shaft). The design and dimensions of the electrode tips vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops or buttons. The system includes single-use electrodes that can be connected to a working element (only WA22366A – K100275), or the use of the single-use electrodes together other compatible electrosurgical cables as applicable. Compatible Generators to any of the electrodes include generators with output specifications that meet the following criteria: 100-120/220-240V, ~50-60Hz/1000VA, 310-380 kHz, 320W/200 Ω, Int 10s/30s.
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