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510(k) K202357

Nutricare Clear-ISOSAF Nasogastric Feeding Tube by Three Circles Consulting Limited — Product Code PIF

K202357 is an FDA 510(k) premarket notification submitted by Three Circles Consulting Limited for the device "Nutricare Clear-ISOSAF Nasogastric Feeding Tube". The FDA issued a decision of Substantially Equivalent on October 1, 2020. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 2020
Date Received
August 19, 2020
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 for product code PIF

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  • 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)

FDA data resources