Cleared Traditional

K834228 - LITHOTRIPTOR ELECTRODE 4.5F

K834228 is an FDA 510(k) clearance for LITHOTRIPTOR ELECTRODE 4.5F, 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 171-day FDA review.

K834228 · Monaghan Medical Corp. · Gastroenterology & Urology device
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May 1984
Decision
171d
Days
Class 2
Risk

K834228 is an FDA 510(k) clearance for the LITHOTRIPTOR ELECTRODE 4.5F. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on May 25, 1984 after a review of 171 days - an extended review 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: 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 Monaghan Medical Corp. devices

FDA 510(k) Submission Details - K834228

510(k) Number K834228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1983
Decision Date May 25, 1984
Days to Decision 171 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
41d slower than avg
Panel avg: 130d · This submission: 171d
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.

Regulatory Peers - FFK Lithotriptor, Electro-hydraulic

All 30
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K834228.
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
K883189 · KARL STORZ Endoscopy-America, Inc. · Feb 1989
MDL-1 LASERTRIPTER
K880503 · Candela Laser Corp. · Jun 1988
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642 · Candela Corp. · Dec 1986
4.5 F LITHOTRIPTOR ELECTRODE
K830086 · Monaghan Medical Corp. · Feb 1983
LITHOTRIPTOR ELECTRODE 4.5F
K822585 · Monaghan Medical Corp. · Sep 1982