Cleared Traditional

K963285 - EMS SWISS LITHOCLAST LITHOTRIPTER

K963285 is an FDA 510(k) clearance for EMS SWISS LITHOCLAST LITHOTRIPTER, manufactured by Electro Medical Systems SA. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K963285 · Electro Medical Systems SA · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
176d
Days
Class 2
Risk

K963285 is an FDA 510(k) clearance for the EMS SWISS LITHOCLAST LITHOTRIPTER. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Electro Medical Systems SA (North Attleboro, US). The FDA issued a Cleared decision on February 13, 1997 after a review of 176 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 Electro Medical Systems SA devices

FDA 510(k) Submission Details - K963285

510(k) Number K963285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1996
Decision Date February 13, 1997
Days to Decision 176 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 131d · This submission: 176d
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 38
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K963285.
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
K974796 · Medispec, Ltd. · Mar 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · Boston Scientific Corp · Jan 1998
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
K974164 · Medical Device Consultants, Inc. · Dec 1997
PULSE GUARD 3FR ELECTRODE
K944571 · Northgate Technologies, Inc. · Mar 1995
RIWOLITH 2280 PROBES
K931755 · Richard Wolf Medical Instruments Corp. · Apr 1994
PULSE GUARD ELECTRODE
K925396 · Northgate Technologies, Inc. · Jul 1993