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FDA 510(k)

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe

K-Number: K153481 · 2016-04-04

ApplicantBecton, Dickinson and Company
Decision Date2016-04-04
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2016-04-04 under approval number K153481. 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 Syringe?

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe is a medical device that received FDA 510(k) clearance on 2016-04-04. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K153481.

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

0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe received FDA 510(k) clearance on 2016-04-04, under approval number K153481.

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

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

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

The FDA product code for 0.9% Sodium Chloride Injection, USP BD PosiFlush SF 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 NCT07513415 A Comparative Study on the Safety and Efficacy of the Intra-Articular Injectable Filler ALLOHEAL in Patients With Knee Osteoarthritis RECRUITING NCT07095946 Effectiveness of Intraligament vs IANB Anesthesia in Children Using Electronic Syringe RECRUITING

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Related Devices (Code: NGT)

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. 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.

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