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FDA 510(k)

TK Pre-Filled Normal Saline Flush Syringe

K-Number: K230756 · 2023-08-12

ApplicantAnhui Tiankang Medical Technology Co., Ltd.
Decision Date2023-08-12
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TK Pre-Filled Normal Saline Flush Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-12 under 510(k) number K230756. 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 TK Pre-Filled Normal Saline Flush Syringe?

TK Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2023-08-12. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K230756.

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

TK Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2023-08-12, under 510(k) number K230756.

Who is the listed applicant for TK Pre-Filled Normal Saline Flush Syringe?

The FDA 510(k) record lists Anhui Tiankang Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TK Pre-Filled Normal Saline Flush Syringe?

The FDA product code for TK Pre-Filled Normal Saline Flush Syringe is NGT.

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Other records listing Anhui Tiankang Medical Technology Co., Ltd. as applicant

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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.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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