Search Results
Found 2 results
510(k) Data Aggregation
K Number
K240504Device Name
PLASMA EDGE System
Manufacturer
Lamidey Noury Medical
Date Cleared
2024-06-12
(112 days)
Product Code
FAS, FDC, GEI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Lamidey Noury Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Plasma Edge System single use bipolar resection electrodes are used for the ablation and hemostasis of tissues under endoscopic control, in association with endoscopic accessories.
They are intended for endoscopic surgeries with saline irrigation, in the field of urology. The use of the Plasma Edge System is restricted to surgeons, specialized in urological surgery, for specific use in:
- Transurethral resection of prostate (TURP) for benign prostatic hypertrophy
- Transurethral incision of the prostate (TUIP) or bladder neck
- Transurethral resection of bladder tumors (TURBT)
- Cystodiathermy
- Transurethral Vaporization of the prostate (TUVP/TVP) for benign prostatic hypertrophy, and for Transurethral Vaporization of bladder tumors. (MVVS models only)
Device Description
The Plasma Edge system is a manual surgical device, consisting of a single-use electrode, an active and passive working element reusable and an adaptor or only socket with memory (fixed cable) to connect them to an HF generator compatible. The electrodes consist of an active tip, two wires threaded through ceramic tubes to connect the active tip to the body of the loop, allowing the HF energy to reach the active tip.
It has to be used with continuous flow irrigation of saline solution (NaCl 0,9%) that reaches the operative site through a resectoscope. The HF energy delivered from the generator to the electrode ionizes the gas of the saline solution, creating a plasma for the cutting, coagulation and vaporization of tissues.
Ask a Question
K Number
K222542Device Name
MCB UNIT Model: V10GMCBUS
Manufacturer
Lamidey Noury Medical
Date Cleared
2022-09-21
(30 days)
Product Code
KNS, GEI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
Lamidey Noury Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrosurgical unit « MCB » is intended for use for the ablation, removal, resection, and coagulation of soft tissue, and where associated hemostasis is required in endoscopic urological surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Device Description
MCB is a reusable, non-sterile electrosurgical bipolar generator with cutting and coagulation modes. The maximum output power is 500 W.
The front panel GUI (graphical user interface) features soft keys and digital displays for:
• the connection status of accessories connected to the electrosurgical generator.
• the current settings of the chosen output mode (Cut/ Coag), and possibility to adjust it
• Sound Level adjustment and LEDs (Green for Sound and Yellow/Blue for output activation)
• Electrode shortcut Alarm reset
At switch on, Serial Number and Software Version are displayed
Ask a Question
Page 1 of 1