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FDA 510(k)

AMSafe(R) Pre-Filled Normal Saline Flush Syringe

K-Number: K183473 · 2019-07-12

ApplicantAmsino International, Inc.
Decision Date2019-07-12
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K183473. 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 AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Amsino International, Inc.. The 510(k) number is K183473.

When did AMSafe(R) Pre-Filled Normal Saline Flush Syringe receive FDA 510(k) clearance?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2019-07-12, under 510(k) number K183473.

Who is the listed applicant for AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

The FDA 510(k) record lists Amsino International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

The FDA product code for AMSafe(R) Pre-Filled Normal Saline Flush Syringe is NGT.

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Other records listing Amsino International, Inc. 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.

K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)K220230AMSure Enteral Feeding PumpK220267AMSafe NeuFlo Needleless ConnectorK213522AMSafe Pre-Filled Normal Saline Flush SyringeK200051PUGGLE Enteral Feeding Pump and Feeding SetK181445AMSure Hydrophilic Intermittent Catheter

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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.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.

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