Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe

K-Number: K191378 · 2019-09-15

ApplicantMedline Industries, Inc.
Decision Date2019-09-15
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2019-09-15 under approval number K191378. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe?

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe is a medical device that received FDA 510(k) clearance on 2019-09-15. It is manufactured by Medline Industries, Inc.. The 510(k) number is K191378.

When was 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe approved by the FDA?

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe received FDA 510(k) clearance on 2019-09-15, under approval number K191378.

What company makes 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe?

0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe is manufactured by Medline Industries, Inc..

What is the FDA product code for 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe?

The FDA product code for 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe is NGT.

Related Clinical Trials

NCT06741657 A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways COMPLETED NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT07557160 Dentapen® vs. Traditional Syringes for Child Dental Anxiety NOT_YET_RECRUITING NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT06918587 A Comparative Evaluation of Pharmacokinetics and Immunogenicity. COMPLETED NCT07513415 A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis RECRUITING

Other Devices by Medline Industries, Inc.

K162829Medline UNITE® Ankle Fracture Plating System K160642Medline ENFit Syringe K161473Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) K152564Gemini Sterilization Wrap K161035Medline Singe Patient Use Blood Pressure Cuff K152458Gemini Bonded Sterilization Wrap

View all 75 devices →

Related Devices (Code: NGT)

K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company K171109Praxiject 0.9% NaClMedxl, Inc. K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company K1733480.9% Sodium Chloride Injection, USPMedline Industries, Inc. K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc. K2012860.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouchNurse Assist, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑