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FDA 510(k)

TK Sterile Piston Syringe without Needle

K-Number: K191642 · 2020-01-06

ApplicantAnhui Tiankang Medical Technology Co., Ltd.
Decision Date2020-01-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TK Sterile Piston Syringe without Needle is a medical device manufactured by Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-01-06 under approval number K191642. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TK Sterile Piston Syringe without Needle?

TK Sterile Piston Syringe without Needle is a medical device that received FDA 510(k) clearance on 2020-01-06. It is manufactured by Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K191642.

When was TK Sterile Piston Syringe without Needle approved by the FDA?

TK Sterile Piston Syringe without Needle received FDA 510(k) clearance on 2020-01-06, under approval number K191642.

What company makes TK Sterile Piston Syringe without Needle?

TK Sterile Piston Syringe without Needle is manufactured by Anhui Tiankang Medical Technology Co., Ltd..

What is the FDA product code for TK Sterile Piston Syringe without Needle?

The FDA product code for TK Sterile Piston Syringe without Needle is FMF.

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Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Anhui Tiankang Medical Technology Co., Ltd.

K191643TK Sterile Hypodermic Needle K191639TK Insulin Syringe with/without Saftey Retractable Device K191640TK Intravascular Administration Set K191644TK Safety Needle K212368Surgical Face Mask K210464Auto Disable Syringe

View all 12 devices →

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, Inc.

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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