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FDA 510(k)

AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)

K-Number: K113587 · 2012-02-24

ApplicantShantou Wealy Medical Instrument Co.,Ltd
Decision Date2012-02-24
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) 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 2012-02-24 under 510(k) number K113587. 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 AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)?

AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) is a medical device that received FDA 510(k) clearance on 2012-02-24. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K113587.

When did AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) receive FDA 510(k) clearance?

AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) received FDA 510(k) clearance on 2012-02-24, under 510(k) number K113587.

Who is the listed applicant for AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)?

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 AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)?

The FDA product code for AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) is MEG.

Related Clinical Trials

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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)K210216Disposable Automatically Retractable Insulin Safety SyringeK203613ENFit Reusable Enteral SyringeK203410ENFit Disposable Enteral Syringe

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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