Monopolar Argon Plasma Coagulation Probes - India CDSCO Medical Device Registration

Monopolar Argon Plasma Coagulation Probes is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000009_48e286234d62b781b3d46d5e8635fdf6_1cb27774c3422d5bf81ce81a869c71fb. This device is marketed under the brand name Electrosurgical Generator ESG-400. The license holder is Olympus Medical Systems India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Monopolar Argon Plasma Coagulation Probes

UID: IMP/MD/2018/000009_48e286234d62b781b3d46d5e8635fdf6_1cb27774c3422d5bf81ce81a869c71fb

Brand Name

Electrosurgical Generator ESG-400

License Holder

Olympus Medical Systems India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The single use and flexible monopolar argon plasma coagulation probes, in conjunction with a compatible Olympus argon plasma coagulation unit and a compatible Olympus electrosurgical generator, are intended to deliver ionized argon gas for monopolar argon plasma coagulation of tissue. Specific intended use Gastrointestinal and respiratory treatments including -- Devitalization of tissue in the gastrointestinal tract such as devitalization of Adenoma Remnants, Barrett’s Esophagus and Zenker’s Diverticulum -- Hemostasis in the gastrointestinal tract such as Radiation Proctitis, Vascular Malformations -- Ablation in the gastrointestinal tract such as Stenoses (Electrosurgical Generator ESG-400) -- Recanalization in the tracheobronchial tree -- Hemostasis in the tracheobronchial tree