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510(k) K901683

IMPROVED BAKER TWIN-CUFF SUMP TUBE by Bissell Medical Products, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 1990
Date Received
April 10, 1990
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 Bissell Medical Products, Inc.

  • K932880 — GRASSI GASTROJEJUNOSTOMY TUBE (June 7, 1995)
  • K914140 — GRASSI GASTROJEJUN TUBE GASTRIC DECOMP/JEJUN FEED (March 31, 1992)
  • K873441 — BAKER TWIN-CUFF INTESTINAL DECOMP/PLICATION TUBE (October 27, 1987)
  • K871691 — MODIFIED MULTI-LUMEN NASOGASTRIC TUBE (August 10, 1987)
  • K851672 — NYHUS/NELSON TUBE (July 9, 1985)

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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)