Home / 510(k) Clearances / K213174

510(k) K213174

Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection by Cardinalhealth — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2022
Date Received
September 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestinal Tubes With Enteral Specific Connectors
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

To facilitate enteral specific connections.

Other clearances by Cardinalhealth

  • K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff (January 14, 2026)
  • K243660 — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syri (August 22, 2025)
  • K243652 — Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syring (December 19, 2024)
  • K230569 — Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Healt (July 3, 2023)
  • K202217 — Kendall NPWT Incision Management Device (June 4, 2021)
  • K191101 — Kendall NPWT Incision Management Dressing Kit (July 31, 2020)
  • K190923 — Salem Sump Dual Lumen Stomach Tube with ENFit Connection (November 7, 2019)
  • K171499 — Occlusion Detection Dressing Kit (September 22, 2017)
  • K161418 — Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Deli (January 19, 2017)
  • K150769 — Cardinal Health Trochanteric IM Nail System (December 14, 2015)

Other clearances for product code PIF

  • K242917 — Enteral Drainage System, Enteral Medicine straw (June 18, 2025)
  • K250481 — Extension Feeding Set with ENFit™ Connectors (April 18, 2025)
  • K240052 — Disposable Enteral Feeding Sets (July 3, 2024)
  • K233034 — Mobility+ Enteral Feeding System OTC (April 12, 2024)
  • K230326 — ENFit to ENFit Extension Sets (November 2, 2023)
  • K232046 — Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT (October 6, 2023)
  • K222773 — Feeding Tube (August 17, 2023)
  • K223683 — EnteraLoc Flow (July 10, 2023)
  • K222678 — Mobility+ Enteral Feeding System (October 27, 2022)
  • K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC (June 9, 2022)