FDA 510(k)

Extracorporeal Shock Wave Lithotripter (U200)

Numéro K : K242922 · 2025-06-18

DemandeurShenzhen Wikkon Precision Technologies Co., Ltd.

Date de décision2025-06-18

Code produitLNS

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Extracorporeal Shock Wave Lithotripter (U200) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Wikkon Precision Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K242922. The device is classified under product code LNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Extracorporeal Shock Wave Lithotripter (U200)?

Extracorporeal Shock Wave Lithotripter (U200) is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Shenzhen Wikkon Precision Technologies Co., Ltd.. The 510(k) number is K242922.

When did Extracorporeal Shock Wave Lithotripter (U200) receive FDA 510(k) clearance?

Extracorporeal Shock Wave Lithotripter (U200) received FDA 510(k) clearance on 2025-06-18, under 510(k) number K242922.

Who is the listed applicant for Extracorporeal Shock Wave Lithotripter (U200)?

The FDA 510(k) record lists Shenzhen Wikkon Precision Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extracorporeal Shock Wave Lithotripter (U200)?

The FDA product code for Extracorporeal Shock Wave Lithotripter (U200) is LNS.

Essais cliniques associés

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Dispositifs connexes (Code : LNS)

K261086Break WaveSonomotion, Inc.K252913Break WaveSonomotion, Inc.K221903Delta III ProDornier Medtech America, Inc.K213772LM-9300 Plus LithotripterLite-Med, Inc.K201001Modulith SLX-F2Karl Storz Endoscopy America K201074Delta III LithotripterDornier Medtech America, Inc.

Source officielle

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