Sterile Field Saline Pre-filled Syringe(s)

• • Terminated Z-0898-2022 FDA Class II ·initiated 4 Mar 2022

  Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field.

510(k) Number

K082837 ↗

FDA Product Code

NGT

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Microbore Extension Set

  Class II

  FDA 510(k) K942349 Active Cleared 8 Feb 1995

• 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe

  Class II

  FDA 510(k) K142620 Active Cleared 12 Dec 2014

• Swabcap

  Class II

  FDA 510(k) K083508 Active Cleared 28 Apr 2009

• Syrex Heparin Lock Flush Syringe, 1 Unit/Ml & 2 Units/Ml

  Class II

  FDA 510(k) K061497 Active Cleared 23 Feb 2007

• Syrex Pre-Filled Syringe

  Class II

  FDA 510(k) K023740 Active Cleared 13 May 2003

• Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride)

  Class II

  FDA 510(k) K962938 Active Cleared 25 Oct 1996

See all devices from Excelsior Medical LLC →

• What is the STERILE FIELD SALINE PRE-FILLED SYRINGE used for?

  This device is a vascular access flush designed specifically for use in a sterile field within a general hospital setting. It is intended for maintaining patency of vascular access devices through saline flushing procedures.

• Is the STERILE FIELD SALINE PRE-FILLED SYRINGE reusable or single-use?

  The device is supplied sterile and intended for single-use only. After use, it should be discarded according to hospital infection control protocols to maintain sterility and prevent cross-contamination.

• What regulatory approvals does the STERILE FIELD SALINE PRE-FILLED SYRINGE have?

  This device has received FDA 510(k) clearance (K082837) and is classified under regulation number 880.5200 with product code NGT. It is substantially equivalent to a predicate device for vascular access flushing in general hospital settings.

• How is the STERILE FIELD SALINE PRE-FILLED SYRINGE supplied?

  The device is supplied in a sterile condition, ready for immediate use in clinical settings. The provided data does not specify packaging details, sizes, or storage conditions beyond its sterile presentation.