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510(k) K234033

ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) by Boehringer Laboratories, LLC — Product Code KNT

K234033 is an FDA 510(k) premarket notification submitted by Boehringer Laboratories, LLC for the device "ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340)". The FDA issued a decision of Substantially Equivalent on May 6, 2024. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Boehringer Laboratories, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 2024
Date Received
December 20, 2023
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 Boehringer Laboratories, LLC

  • K243399 — Boehringer Laboratories Liver Retractor (July 2, 2025)
  • K234145 — ViSiGi 3D Gastric Sizing Tube (January 26, 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

  • K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blake (July 10, 2026)
  • 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)

FDA data resources