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510(k) K800507

FEEDING TUBES by Medi-Craft , Ltd. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1980
Date Received
March 4, 1980
Clearance Type
Traditional
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 Medi-Craft , Ltd.

  • K861949 — SUCTION CATHETER KIT (October 22, 1986)
  • K800510 — RECTAL & HARRIS FLUSH TUBES (April 8, 1980)
  • K800505 — URETHRAL CATHETER (April 8, 1980)
  • K800508 — STOMACH TUBES (April 8, 1980)
  • K800506 — OXYGEN CATHETER (March 25, 1980)
  • K800509 — CONNECTING TUBES (March 25, 1980)
  • K800503 — SUCTION CATHETER (March 18, 1980)
  • K800504 — OXYGEN CONNECTING TUBES (March 18, 1980)

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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)