Cleared Traditional

K002801 - MPS M ELECTRODE

K002801 is an FDA 510(k) clearance for MPS M ELECTRODE, manufactured by Medical Physics and Services, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LNS cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K002801 · Medical Physics and Services, Inc. · Gastroenterology & Urology device
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May 2001
Decision
238d
Days
Class 2
Risk

K002801 is an FDA 510(k) clearance for the MPS M ELECTRODE. Classified as Lithotriptor, Extracorporeal Shock-wave, Urological (product code LNS), Class II - Special Controls.

Submitted by Medical Physics and Services, Inc. (Denver, US). The FDA issued a Cleared decision on May 4, 2001 after a review of 238 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 Medical Physics and Services, Inc. devices

FDA 510(k) Submission Details - K002801

510(k) Number K002801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 08, 2000
Decision Date May 04, 2001
Days to Decision 238 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 130d · This submission: 238d
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 Peers - LNS Lithotriptor, Extracorporeal Shock-wave, Urological

All 18
Devices cleared under the same product code (LNS) and FDA review panel - the closest regulatory comparables to K002801.
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