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510(k) K992494

FLEXIFLO ENTERAL FEEDING TUBE by Ross Product Div. Abbott Laboratories — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1999
Date Received
July 26, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Ross Product Div. Abbott Laboratories

  • K031407 — ROSS EMBRACE ENTERAL PUMP (May 20, 2003)
  • K003047 — AMBULATORY ENTERAL NUTRITION PUMP (June 12, 2001)
  • K990863 — MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE (April 6, 1999)

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  • K242901 — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN (January 10, 2025)
  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)