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FDA 510(k)

Syringe with permanently attached needle

K-Number: K213158 · 2022-07-21

ApplicantBerpu Medical Technology Co., Ltd.
Decision Date2022-07-21
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Syringe with permanently attached needle is a medical device manufactured by Berpu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-21 under approval number K213158. 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 Syringe with permanently attached needle?

Syringe with permanently attached needle is a medical device that received FDA 510(k) clearance on 2022-07-21. It is manufactured by Berpu Medical Technology Co., Ltd.. The 510(k) number is K213158.

When was Syringe with permanently attached needle approved by the FDA?

Syringe with permanently attached needle received FDA 510(k) clearance on 2022-07-21, under approval number K213158.

What company makes Syringe with permanently attached needle?

Syringe with permanently attached needle is manufactured by Berpu Medical Technology Co., Ltd..

What is the FDA product code for Syringe with permanently attached needle?

The FDA product code for Syringe with permanently attached needle is FMF.

Related Clinical Trials

NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT06411054 The Efficacy of Acu-TENS as an Adjunct Analgesic During USG-MVA RECRUITING NCT02119611 Deep Brain Stimulation Therapy in Movement Disorders RECRUITING NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT06253494 Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer RECRUITING NCT07498621 Assessment of Maxillary Local Anesthesia Infiltration Using Needle-free Jet vs Conventional Syringe in Tooth Extraction COMPLETED

Other Devices by Berpu Medical Technology Co., Ltd.

K162180Disposable Insulin Syringe K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use K181447Safety insulin needle for single use K221045Insulin Syringes without needle K220061Safety Insulin Syringes K213811Sterile Hypodermic Syringes for Single Use

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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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