Cleared Traditional

K242922 - Extracorporeal Shock Wave Lithotripter ...

K242922 is an FDA 510(k) clearance for Extracorporeal Shock Wave Lithotripter ..., manufactured by Shenzhen Wikkon Precision Technologies Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K242922 · Shenzhen Wikkon Precision Technologies Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
267d
Days
Class 2
Risk

K242922 is an FDA 510(k) clearance for the Extracorporeal Shock Wave Lithotripter (U200). Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Shenzhen Wikkon Precision Technologies Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 18, 2025 after a review of 267 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5990 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Wikkon Precision Technologies Co., Ltd. devices

FDA 510(k) Submission Details - K242922

510(k) Number K242922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2024
Decision Date June 18, 2025
Days to Decision 267 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 130d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LNS Device Classification - Class 2, Special Controls

Product Code LNS Lithotriptor, Extracorporeal Shock-wave, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5990
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Consultant

Qimmiq Medical Consulting Service Co., Ltd.
Yijie You

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LNS Lithotriptor, Extracorporeal Shock-wave, Urological

All 17
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K242922.
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K261086 · Sonomotion, Inc. · Apr 2026
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LM-9300 Plus Lithotripter
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Modulith SLX-F2
K201001 · Karl Storz Endoscopy America · Mar 2021
Delta III Lithotripter
K201074 · Dornier Medtech America, Inc. · Sep 2020