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HSA · registration DE0510473

Cook Instinct Plus® Endoscopic Clipping Device

SingaporeGastroenterology & UrologyClass CWilson-Cook Medical, Inc
Official record identity
Registration number
DE0510473
Model name
Instinct Plus™ Endoscopic Clipping Device
Model identifier
INSC-P-7-230-S
Registration date
March 17, 2025
Source update date
April 13, 2026
Classification
Risk class
Class C
Official value: CLASS C
Published category
Gastroenterology & Urology
Published parties
Registrant / registration holder
COOK SOUTH EAST ASIA PTE LTD
Official 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.

Additional source fields
Product owner address
4900 Bethania Station Road, Winston-Salem, NC 27105, United States
Registrant address
38 BEACH ROAD, #29-11, SOUTH BEACH TOWER, Singapore 189767
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.