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FDA 510(k)

Shina Syringe; Shina Safety Syringe

K-Number: K231165 · 2023-10-27

ApplicantShina Med Corporation
Decision Date2023-10-27
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Shina Syringe; Shina Safety Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shina Med Corporation. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K231165. 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 Shina Syringe; Shina Safety Syringe?

Shina Syringe; Shina Safety Syringe is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Shina Med Corporation. The 510(k) number is K231165.

When did Shina Syringe; Shina Safety Syringe receive FDA 510(k) clearance?

Shina Syringe; Shina Safety Syringe received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231165.

Who is the listed applicant for Shina Syringe; Shina Safety Syringe?

The FDA 510(k) record lists Shina Med Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Shina Syringe; Shina Safety Syringe?

The FDA product code for Shina Syringe; Shina Safety Syringe is MEG.

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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.K231907Medline 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, LLCK220114PowerPAK SyringeVault Paragon Group, 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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