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FDA 510(k)

Jeesung Safety Syringe and Single Use Needles

K-Number: K212518 · 2022-08-18

ApplicantJeesung Medical Co., Ltd.
Decision Date2022-08-18
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Jeesung Safety Syringe and Single Use Needles is the device name listed in this FDA 510(k) record. The listed applicant is Jeesung Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-08-18 under 510(k) number K212518. 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 Jeesung Safety Syringe and Single Use Needles?

Jeesung Safety Syringe and Single Use Needles is a medical device that received FDA 510(k) clearance on 2022-08-18. The listed applicant is Jeesung Medical Co., Ltd.. The 510(k) number is K212518.

When did Jeesung Safety Syringe and Single Use Needles receive FDA 510(k) clearance?

Jeesung Safety Syringe and Single Use Needles received FDA 510(k) clearance on 2022-08-18, under 510(k) number K212518.

Who is the listed applicant for Jeesung Safety Syringe and Single Use Needles?

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

What is the FDA product code for Jeesung Safety Syringe and Single Use Needles?

The FDA product code for Jeesung Safety Syringe and Single Use Needles is MEG.

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Other records listing Jeesung Medical Co., Ltd. as applicant

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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