Cleared Traditional

K913487 - RIWOLITH 2280

K913487 is an FDA 510(k) clearance for RIWOLITH 2280, manufactured by Richard Wolf Medical Instruments Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K913487 · Richard Wolf Medical Instruments Corp. · Gastroenterology & Urology device
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Feb 1992
Decision
183d
Days
Class 2
Risk

K913487 is an FDA 510(k) clearance for the RIWOLITH 2280. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Richard Wolf Medical Instruments Corp. (Rosemont, US). The FDA issued a Cleared decision on February 5, 1992 after a review of 183 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 Richard Wolf Medical Instruments Corp. devices

FDA 510(k) Submission Details - K913487

510(k) Number K913487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1991
Decision Date February 05, 1992
Days to Decision 183 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 131d · This submission: 183d
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 41
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K913487.
PULSE GUARD ELECTRODE
K925396 · Northgate Technologies, Inc. · Jul 1993
AUTOLITH-IEHL
K923822 · Northgate Technologies, Inc. · Jan 1993
SD-200IEHL(TM)
K914517 · Northgate Technologies, Inc. · Jun 1992
3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914515 · Northgate Technologies, Inc. · Jan 1992
9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914516 · Northgate Technologies, Inc. · Jan 1992
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K914514 · Northgate Technologies, Inc. · Jan 1992