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FDA 510(k)

Flush Syringe (Prefilled 0.9% normal saline solution)

K-Number: K231724 · 2023-11-09

ApplicantSpm Medicare Pvt. , Ltd.
Decision Date2023-11-09
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Flush Syringe (Prefilled 0.9% normal saline solution) is the device name listed in this FDA 510(k) record. The listed applicant is Spm Medicare Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231724. 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 Flush Syringe (Prefilled 0.9% normal saline solution)?

Flush Syringe (Prefilled 0.9% normal saline solution) is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Spm Medicare Pvt. , Ltd.. The 510(k) number is K231724.

When did Flush Syringe (Prefilled 0.9% normal saline solution) receive FDA 510(k) clearance?

Flush Syringe (Prefilled 0.9% normal saline solution) received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231724.

Who is the listed applicant for Flush Syringe (Prefilled 0.9% normal saline solution)?

The FDA 510(k) record lists Spm Medicare Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution)?

The FDA product code for Flush Syringe (Prefilled 0.9% normal saline solution) is NGT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06339203Wound Irrigation With Saline Versus Hypodilute-chlorhexidine After Cesarean Section (WISHES Study)RECRUITINGNCT07321704Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal DiseaseRECRUITINGNCT07534865Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral WartsRECRUITING

Other records listing Spm Medicare Pvt. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233794Insulin Syringe

Related Devices (Code: NGT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and CompanyK233623Praxiject™ SP 0.9% NaClMedxl, Inc.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.K2311610.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush SyringeBecton, Dickinson and Company

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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