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510(k) K841349

ESOPHAGEAL TUBE by E. Benson Hood Laboratories, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1984
Date Received
April 2, 1984
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 E. Benson Hood Laboratories, Inc.

  • K983878 — CZAJA-MCCAFFREY RIGID STENT INTRODUCER/ENDOSCOPE (January 29, 1999)
  • K841350 — SALIVARY BYPASS TUBE (July 26, 1984)
  • K841266 — MONTGOMERY TRACHEAL T-TUBE (June 14, 1984)
  • K841347 — LARYNGEAL STENT (May 2, 1984)
  • K841348 — UMBRELLA KEEL (May 2, 1984)

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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)