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FDA 510(k)

Insulin Syringe, Insulin Syringe with Safety Retractable

K-Number: K202570 · 2021-07-02

ApplicantJiangsu Micsafe Medical Technology Co., Ltd.
Decision Date2021-07-02
Product CodeMEG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Insulin Syringe, Insulin Syringe with Safety Retractable is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K202570. 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 Insulin Syringe, Insulin Syringe with Safety Retractable?

Insulin Syringe, Insulin Syringe with Safety Retractable is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K202570.

When did Insulin Syringe, Insulin Syringe with Safety Retractable receive FDA 510(k) clearance?

Insulin Syringe, Insulin Syringe with Safety Retractable received FDA 510(k) clearance on 2021-07-02, under 510(k) number K202570.

Who is the listed applicant for Insulin Syringe, Insulin Syringe with Safety Retractable?

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

What is the FDA product code for Insulin Syringe, Insulin Syringe with Safety Retractable?

The FDA product code for Insulin Syringe, Insulin Syringe with Safety Retractable is MEG.

Other records listing Jiangsu Micsafe Medical Technology 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.

K212019Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for SingleK202205Surgical Face MaskK183665Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single UseK181426Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)

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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