Medsurg Insertion Tray

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K920780 ↗

FDA Product Code

LFJ

Device Class

Class II

Regulation

21 CFR Part 876.5540

Advisory Committee

Gastroenterology, Urology

FDA Decision

SEKD

• Sterile Scrubby Scrub Brush

  Class I

  FDA 510(k) K875033 Active Cleared 19 Feb 1988

• Medsurg Custom Dressing Trays

  Not classified

  FDA 510(k) K861693 Active Cleared 8 Jul 1986

• Medsurg 7 Fr. Dual Lumen Central Vein Cath System

  Class II

  FDA 510(k) K880771 Active Cleared 3 May 1988

• Medsurg Circumcision Tray

  Class II

  FDA 510(k) K920838 Active Cleared 15 Oct 1993

• Medsurg Single Use Basin Set

  Not classified

  FDA 510(k) K861784 Active Cleared 21 May 1986

• Medsurg Epidural Tray/19 Gage Open End Tuohy 1012

  Class II

  FDA 510(k) K890733 Active Cleared 23 Jun 1989

See all devices from Medsurg Industries, Inc. →

• What is the Medsurg Insertion Tray used for?

  The Medsurg Insertion Tray is intended for subclavian catheter insertion in clinical settings, specifically supporting procedures in gastroenterology and urology as indicated by the advisory committee review associated with its FDA 510(k) clearance.

• How is the Medsurg Insertion Tray supplied and what does it include?

  The device is supplied as a kit that includes drugs, as indicated by the decision code SEKD (Substantially Equivalent - Kit With Drugs), meaning it is packaged with pharmaceutical agents for use during subclavian catheter insertion procedures.

• What regulatory pathway was used for the Medsurg Insertion Tray?

  The Medsurg Insertion Tray received FDA 510(k) clearance through a traditional submission process, with clearance granted on August 19, 1994, under K920780, based on its classification under product code LFJ and regulation number 876.5540.