F00010 - IV GRAVITY SETWITH MALE LUER SLIP - F00027 - Iv Gravity Set With Male Luer Lock

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K042129 ↗

FDA Product Code

FPA

Models / Variants

F00010 - Iv Gravity Setwith Male Luer Slip

F00027 - Iv Gravity Set With Male Luer Lock

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Enteral Feeding Spike Adapter

  Class II

  FDA 510(k) K072652 Active Cleared 18 Jan 2008

• Cedic Oral/Luer Enteral ENFit Transition Connector for Medication Port

  Class II

  FDA 510(k) K150010 Active Cleared 2 Apr 2015

• Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes

  Class II

  FDA 510(k) K181787 Active Cleared 25 Apr 2019

• Cedic Enteral Distal End Enfit Transition Connector

  Class II

  FDA 510(k) K140581 Active Cleared 17 Oct 2014

• Cedic Enteral ENFit Transition Connectors

  Class II

  FDA 510(k) K162254 Active Cleared 4 May 2017

• ENConnect 40 mm Screw Cap to ENPlus Adapter

  Class II

  FDA 510(k) K190327 Active Cleared 9 Apr 2019