Cleared Traditional

K830086 - 4.5 F LITHOTRIPTOR ELECTRODE

K830086 is an FDA 510(k) clearance for 4.5 F LITHOTRIPTOR ELECTRODE, manufactured by Monaghan Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K830086 · Monaghan Medical Corp. · Gastroenterology & Urology device
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Feb 1983
Decision
29d
Days
Class 2
Risk

K830086 is an FDA 510(k) clearance for the 4.5 F LITHOTRIPTOR ELECTRODE. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Walker, US). The FDA issued a Cleared decision on February 9, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4480 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K830086

510(k) Number K830086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date February 09, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FFK Device Classification - Class 2, Special Controls

Product Code FFK Lithotriptor, Electro-hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4480
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.