Defect closure system - India CDSCO Medical Device Registration

Defect closure system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000445_a92ecc3707509a8b6f063001e380c773_87709b9ce4e9251c6dc1c1b3ce8a3216. This device is marketed under the brand name Padlock Clip®. The license holder is STERIS 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

Defect closure system

UID: IMP/MD/2023/000445_a92ecc3707509a8b6f063001e380c773_87709b9ce4e9251c6dc1c1b3ce8a3216

Brand Name

Padlock Clip®

License Holder

STERIS INDIA PVT LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Padlock Clip® is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs. The Padlock Clip® is indicated for clip placement within the gastrointestinal (Padlock Clip®) tract for the purpose of: • Endoscopic marking of lesions • Hemostasis for: o Mucosal/Submucosal defects o Bleeding Ulcers o Arteries <2mm o Polyps <1.5cm in diameter o Diverticula in the Colon • Closure of GI tract luminal perforations <20mm that can be treated conservatively