Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sterile Single-use Syringe with Needle

K-Number: K163161 · 2017-03-20

ApplicantJiangxi Hongda Medical Equipment Group , Ltd.
Decision Date2017-03-20
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Single-use Syringe with Needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163161. 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 Sterile Single-use Syringe with Needle?

Sterile Single-use Syringe with Needle is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163161.

When did Sterile Single-use Syringe with Needle receive FDA 510(k) clearance?

Sterile Single-use Syringe with Needle received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163161.

Who is the listed applicant for Sterile Single-use Syringe with Needle?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Single-use Syringe with Needle?

The FDA product code for Sterile Single-use Syringe with Needle is FMF.

Other records listing Jiangxi Hongda Medical Equipment Group , 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.

K211753Sterile Syringe With Safety NeedleK210622Single-Use Medical Face MaskK210578Medical Nitrile Examination Gloves (Power free, Blue)K210821Medical PVC Examination GlovesK163160Sterile Single-use Infusion SetK163162Sterile Hypodermic Safety Syringes for Single Use

View all 7 devices →

Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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.

↑