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FDA 510(k)

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use

K-Number: K192679 · 2020-04-10

ApplicantGemtier Medical (Shanghai), Inc.
Decision Date2020-04-10
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Gemtier Medical (Shanghai), Inc.. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K192679. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use?

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Gemtier Medical (Shanghai), Inc.. The 510(k) number is K192679.

When did Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use receive FDA 510(k) clearance?

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use received FDA 510(k) clearance on 2020-04-10, under 510(k) number K192679.

Who is the listed applicant for Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use?

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

What is the FDA product code for Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use?

The FDA product code for Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use is MEG.

Other records listing Gemtier Medical (Shanghai), 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.

K212652Sterile Syringe with Fixed Safety Needle for Single UseK202493Medical Face MaskK202331Medical Face MaskK170276Safety Blood Collection Device for Single Use

Related Devices (Code: MEG)

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.

K252098PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)Methyl Co., Ltd.K250847VaporShieldVault Paragon Group, Inc.K230287SaviSafe Safety DeviceSuzhou Savicred Biotechnology Co., Ltd.K231165Shina Syringe; Shina Safety SyringeShina Med CorporationK231907Medline Safety Insulin and TB SyringesMedline Industries, LPK223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

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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