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 BD PosiFlush™ SF Saline Flush Syringe

K-Number: K231161 · 2023-07-21

ApplicantBecton, Dickinson and Company
Decision Date2023-07-21
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-07-21 under approval number K231161. 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 BD PosiFlush™ SF Saline Flush Syringe?

0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2023-07-21. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K231161.

When was 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe approved by the FDA?

0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe received FDA 510(k) clearance on 2023-07-21, under approval number K231161.

What company makes 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe?

0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe is manufactured by Becton, Dickinson and Company.

What is the FDA product code for 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe?

The FDA product code for 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe is NGT.

Related Clinical Trials

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 NCT02539095 Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection COMPLETED NCT04559334 Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients SUSPENDED

Other Devices by Becton, Dickinson and Company

K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe K162516BD Pen Needle K160657BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube K151589BD MAX CT/GC/TV, BD MAX INSTRUMENT K151870BD U-500 INSULIN SYRINGE K161553BD SafeAssist

View all 100 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. K1913780.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeMedline Industries, Inc. K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeAmsino International, Inc.

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.

↑