FDA 510(k)

0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe

K-Number: K231161 · 2023-07-21

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 the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-07-21 under 510(k) 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. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K231161.

When did 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe receive FDA 510(k) clearance?

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

Who is the listed applicant for 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: NGT)

K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.

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.