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CDSCO UID IMP/MD/2022/000626_b468cc0639998cbc02e3f086feff6d80_7ae50b7a2e7e7d8f4a4f91f3aaa36b4b

Endoscope

Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India·Device Class Class B·India CDSCO·Brand: da Vinci - Si/X/Xi
Registration details
UID
IMP/MD/2022/000626_b468cc0639998cbc02e3f086feff6d80_7ae50b7a2e7e7d8f4a4f91f3aaa36b4b
Device class
Class B
Brand name
da Vinci - Si/X/Xi
License holder
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Approving authority
CDSCO
Product information
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urological surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology robotic surgical procedures restricted to benign and malignant tumors classified as Tl and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (da Vinci - Si/X/Xi). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. The Intuitive Surgical 8.5 mm Endoscopic System is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery in the peritoneal cavity, thoracic cavity, and peritoneum. It is designed for use with the Intuitive Surgical da Vinci Si Instrument Control System during laparoscopic and thoracoscopic surgical procedures.
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Other products with the same name or brand
Endoscope
KARL STORZ ENDOSCOPY INDIA PRIVATE LIMITED
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Endoscope
Brand: SureForm - 45/45 Curved-Tip/60
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
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Endoscope
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
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Accessory
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Class A
Cannula
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Class B
Hasson Cone
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Class B
Drapes
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Class A
Cannula
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Class B
Cannula
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Class B
Hasson Cone
Brand: da Vinci - Si/X/Xi
Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Class B
Other products from Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India
Products from the same license holder (10 products)
Clip Applier
Brand: SureForm - 45/45 Curved-Tip/60
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Suction Irrigator Instrument
Brand: SureForm - 45/45 Curved-Tip/60
Class B
Endoscope
Brand: SureForm - 45/45 Curved-Tip/60
Class B
Accessory
Brand: 8 mm Endoscope Washer/ Disinfector Connector Set
Class A
Accessory
Brand: SureForm - 45/45 Curved-Tip/60
Class B
Retractor
Brand: SureForm - 45/45 Curved-Tip/60
Class B
Needle Driver Instrument
Brand: SureForm - 45/45 Curved-Tip/60
Class B
Obturator(8 mm Bladeless Obturator/ 8mm Bladeless Obturator, Long )
Brand: SureForm - 45/45 Curved-Tip/60
Class B
Stapler Instrument
Brand: SureForm - 45/45 Curved-Tip/60
Class B
Scissors
Brand: SureForm - 45/45 Curved-Tip/60
Class B
About this record

Endoscope is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000626_b468cc0639998cbc02e3f086feff6d80_7ae50b7a2e7e7d8f4a4f91f3aaa36b4b. This device is marketed under the brand name da Vinci - Si/X/Xi. The license holder is Intuitive Surgical India Pvt Ltd ,C/O Expeditors International Pvt. Ltd., Shed No.2., SY. No. 42/9 & 42/10, Adjacent to ITC Factory, KIA ROAD, DODDAJALA GATE & POST. ,Bengaluru (Bangalore) Rural Karnataka ,562157 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.

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