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510(k) K254170

Percutaneous Endoscopic Gastrostomy (PEG) Kit by Degania Silicone , Ltd. — Product Code PIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2026
Date Received
December 23, 2025
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 Degania Silicone , Ltd.

  • K233591 — Stylus (May 31, 2024)
  • K152246 — Aquarius Stoma Measuring Device (June 21, 2016)
  • K143378 — AQUARIUS Gastrostomy Replacement Tube (December 29, 2014)
  • K141753 — AQUARIUS NASAL FEEDING TUBE (October 16, 2014)
  • K141631 — AQUARIUS EXTENSION FEEDING SET (July 28, 2014)
  • K132686 — AQUARIUS LOW PROFILE GASTROSTOMY FEEDING TUBE (May 12, 2014)
  • K131020 — TEMPERATURE SENSOR CATHETER (May 9, 2013)
  • K122030 — LOW PROFILE GASTROSTOMY FEEDING TUBE OR GASTROTOMEY BUTTON (September 5, 2012)
  • K103371 — COUDE/ OR TIEMANN (March 11, 2011)
  • K070124 — GASTROSTOMY REPLACEMENT TUBE, MODEL 253 (May 23, 2007)

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)
  • K213258 — Nasogastric Feeding Tubes - ENFit Port - PVC (June 9, 2022)