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510(k) K833054

GASTRIC SUMP TUBES by Medovations, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1983
Date Received
September 7, 1983
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 Medovations, Inc.

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  • K972119 — MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX) (February 2, 1998)
  • K924646 — OVER THE GUIDEWIRE DILATATION SYSTEM (December 5, 1994)
  • K913678 — TROCAR CATHETER (December 16, 1991)
  • K905478 — YANKAUER SUCTION DEVICE (December 19, 1990)
  • K874309 — URETHAL CATHETER (December 7, 1987)
  • K864963 — STOMACH EVACULATOR - EWALD STYLE (October 14, 1987)
  • K864962 — OBERTO MOUTH PROP (February 19, 1987)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)

Other clearances for product code KNT

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  • K243228 — Flexi-Seal AIR (with ENFit Connector) (March 28, 2025)
  • K242336 — hygh-tec Drainage II (January 17, 2025)
  • 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)