Product Classification

• Device: tube, gastro-enterostomy
• Regulation Description: Gastrointestinal tube and accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: KGC
• Premarket Review: Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
• Submission Type: 510(k)
• Regulation Number: 876.5980
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 5-123 ISO 80369-3 First Edition 2016-07-01
  Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
• 5-139 ISO 18250-3 First edition 2018-06
  Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
• 9-31 AAMI ANSI ID54:1996/(R)2012
  Enteral feeding set adapters and connectors
• 9-138 ISO 20695 First edition 2020-03
  Enteral feeding systems - Design and testing

Guidance Document

• Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications - Guidance for Industry and Food and Drug Administration Staff

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc