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FDA 510(k)

Introducer Needle

K-Number: K222705 · 2023-05-22

ApplicantYoucare Technology Co.,Ltd. (Wuhan)
Decision Date2023-05-22
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

Introducer Needle is the device name listed in this FDA 510(k) record. The listed applicant is Youcare Technology Co.,Ltd. (Wuhan). It received FDA 510(k) clearance on 2023-05-22 under 510(k) number K222705. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Introducer Needle?

Introducer Needle is a medical device that received FDA 510(k) clearance on 2023-05-22. The listed applicant is Youcare Technology Co.,Ltd. (Wuhan). The 510(k) number is K222705.

When did Introducer Needle receive FDA 510(k) clearance?

Introducer Needle received FDA 510(k) clearance on 2023-05-22, under 510(k) number K222705.

Who is the listed applicant for Introducer Needle?

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

What is the FDA product code for Introducer Needle?

The FDA product code for Introducer Needle is LJE.

Other records listing Youcare Technology Co.,Ltd. (Wuhan) 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.

K230748Disposable Ureteral Access Sheath

Related Devices (Code: LJE)

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.

K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook IncorporatedK190903Lawson Retrograde Nephrostomy Wire Puncture SetCook IncorporatedK183051Kaye Nephrostomy Tamponade Balloon Catheter and Stent SetCook Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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