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Cook Instinct Plus™ Endoscopic Clipping Device - HSA Registration DE0510473

Access comprehensive regulatory information for Cook Instinct Plus™ Endoscopic Clipping Device in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510473 and owned by Wilson-Cook Medical, Inc. The device was registered on March 17, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0510473
Cook Instinct Plus™ Endoscopic Clipping Device
HSA Registration Number: DE0510473
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Product Description

This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking, 2.Hemostasis for • Mucosal/submucosal defects less than 3 cm, • Bleeding ulcers, • Arteries less than 2 mm, • Polyps less than 1.5 cm in diameter, • Diverticula in the colon, and • Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection, 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel, 4. As a supplementary method for closure of GI tract luminal perforations less than 20 mm that can be treated conservatively, 5. Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0510473
Registration Date
March 17, 2025
Retention Due Date
March 16, 2026
Product Owner
Short Name
Wilson-Cook Medical
Address
4900 Bethania Station Road, Winston-Salem, NC 27105, UNITED STATES
Registrant
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Importer
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Model Information
Model Name(s)
Instinct Plus™ Endoscopic Clipping Device
Model Identifier(s)
INSC-P-7-230-S