FDA 510(k)

Disposable Automatically Retractable Insulin Safety Syringe

K-Number: K210216 · 2022-03-04

ApplicantShantou Wealy Medical Instrument Co.,Ltd

Decision Date2022-03-04

Product CodeMEG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Disposable Automatically Retractable Insulin Safety Syringe is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K210216. 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 Disposable Automatically Retractable Insulin Safety Syringe?

Disposable Automatically Retractable Insulin Safety Syringe is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K210216.

When did Disposable Automatically Retractable Insulin Safety Syringe receive FDA 510(k) clearance?

Disposable Automatically Retractable Insulin Safety Syringe received FDA 510(k) clearance on 2022-03-04, under 510(k) number K210216.

Who is the listed applicant for Disposable Automatically Retractable Insulin Safety Syringe?

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

What is the FDA product code for Disposable Automatically Retractable Insulin Safety Syringe?

The FDA product code for Disposable Automatically Retractable Insulin Safety Syringe is MEG.

Other records listing Shantou Wealy Medical Instrument Co.,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.

K222452Disposable Automatically Retractable Safety Syringes (with detachable needle)K203613ENFit Reusable Enteral Syringe K203410ENFit Disposable Enteral Syringe

Related Devices (Code: MEG)

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 Corporation K231907Medline Safety Insulin and TB SyringesMedline Industries, LP K223376Monoject 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.