Cleared Traditional

K832566 - COAXIAL ELECTRODE #300A

K832566 is an FDA 510(k) clearance for COAXIAL ELECTRODE #300A, manufactured by K-Med, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K832566 · K-Med, Inc. · Gastroenterology & Urology device
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Nov 1983
Decision
118d
Days
Class 2
Risk

K832566 is an FDA 510(k) clearance for the COAXIAL ELECTRODE #300A. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by K-Med, Inc. (Walker, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 118 days - within the typical 510(k) review window.

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 K-Med, Inc. devices

FDA 510(k) Submission Details - K832566

510(k) Number K832566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1983
Decision Date November 28, 1983
Days to Decision 118 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 131d · This submission: 118d
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 48
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K832566.
MDL-1 LASERTRIPTER
K880503 · Candela Laser Corp. · Jun 1988
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642 · Candela Corp. · Dec 1986
LITHOTRIPTOR ELECTRODE 4.5F
K834228 · Monaghan Medical Corp. · May 1984
4.5 F LITHOTRIPTOR ELECTRODE
K830086 · Monaghan Medical Corp. · Feb 1983
LITHOTRIPTOR ELECTRODE 4.5F
K822585 · Monaghan Medical Corp. · Sep 1982