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510(k) K190414

Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV by Moss Tubes, Inc. — Product Code PIF

K190414 is an FDA 510(k) premarket notification submitted by Moss Tubes, Inc. for the device "Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV". The FDA issued a decision of Substantially Equivalent on June 14, 2019. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Moss Tubes, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2019
Date Received
February 21, 2019
Clearance Type
Special
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 Moss Tubes, Inc.

  • K990389 — MOSS GASTROSTOMY TUBE (March 22, 1999)
  • K984628 — MODIFICATION OF MOSS P.E.G. TRAY (March 17, 1999)
  • K984629 — MOSS TUBES, INC. NASAL TUBE - MARK IV (March 2, 1999)
  • K984310 — MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE (February 24, 1999)

Other clearances for product code PIF

  • K254170 — Percutaneous Endoscopic Gastrostomy (PEG) Kit (March 20, 2026)
  • 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)

FDA data resources