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510(k) K234145

ViSiGi 3D Gastric Sizing Tube by Boehringer Laboratories — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2024
Date Received
December 29, 2023
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 Boehringer Laboratories

  • K243399 — Boehringer Laboratories Liver Retractor (July 2, 2025)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)
  • K151990 — Tissue Removal System (September 11, 2015)
  • K150781 — Tissue Removal Pouch (June 19, 2015)
  • K130483 — BOEHRINGER GASTRIC SIZING TUBE (March 28, 2013)
  • K061788 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (July 11, 2006)
  • K060277 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM (March 3, 2006)
  • K020538 — BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES (May 15, 2002)
  • K014187 — AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM (February 6, 2002)
  • K013976 — BOEHRINGER MRI SUCTION REGULATORY (January 8, 2002)

Other clearances for product code KNT

  • K250389 — XNY Disposable Gastric Calibration Tube (April 10, 2025)
  • 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)