FDA 510(k)

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle

Numéro K : K221247 · 2022-11-01

DemandeurJiangsu Kangbao Medical Equipment Co., Ltd.

Date de décision2022-11-01

Code produitMEG

Comité consultatifHO

DécisionSubstantially Equivalent

Résumé du dispositif

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2022-11-01 under 510(k) number K221247. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle?

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle is a medical device that received FDA 510(k) clearance on 2022-11-01. The listed applicant is Jiangsu Kangbao Medical Equipment Co., Ltd.. The 510(k) number is K221247.

When did Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle receive FDA 510(k) clearance?

Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle received FDA 510(k) clearance on 2022-11-01, under 510(k) number K221247.

Who is the listed applicant for Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle?

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

What is the FDA product code for Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle?

The FDA product code for Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle is MEG.

Essais cliniques associés

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Autres dossiers indiquant Jiangsu Kangbao Medical Equipment Co., Ltd. en tant que demandeur

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Dispositifs connexes (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

Source officielle

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