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FDA 510(k)

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization

K-Number: K220057 · 2022-10-07

ApplicantShinva Ande Healthcare Apparatus Co., Ltd.
Decision Date2022-10-07
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is the device name listed in this FDA 510(k) record. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K220057. 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 Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization?

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Shinva Ande Healthcare Apparatus Co., Ltd.. The 510(k) number is K220057.

When did Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization receive FDA 510(k) clearance?

Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization received FDA 510(k) clearance on 2022-10-07, under 510(k) number K220057.

Who is the listed applicant for Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization?

The FDA 510(k) record lists Shinva Ande Healthcare Apparatus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization?

The FDA product code for Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization is MEG.

Other records listing Shinva Ande Healthcare Apparatus 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.

K201460Closed System Transfer DeviceK211484Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety NeedlesK202060Disposable IV catheterK193657Disposable Enteral Feeding Syringe with Enfit ConnectorK162601Infusion Set 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

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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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