Cleared Traditional

K974796 - LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER

K974796 is an FDA 510(k) clearance for LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER, manufactured by Medispec, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K974796 · Medispec, Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
80d
Days
Class 2
Risk

K974796 is an FDA 510(k) clearance for the LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Medispec, Ltd. (Montgomery Village, US). The FDA issued a Cleared decision on March 12, 1998 after a review of 80 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 Medispec, Ltd. devices

FDA 510(k) Submission Details - K974796

510(k) Number K974796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1997
Decision Date March 12, 1998
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
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 31
Devices cleared under the same product code (FFK) and FDA review panel - the closest regulatory comparables to K974796.
KSEA CALCUSPLIT
K992114 · Karl Storz Endoscopy · Aug 1999
ELECTRO MECHANICAL LITHOTRIPTOR
K990341 · Northgate Technologies, Inc. · Jul 1999
KSEA CALCUSPLIT
K981233 · KARL STORZ Endoscopy-America, Inc. · Jun 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · Boston Scientific Corp · Jan 1998
PULSE GUARD 3FR ELECTRODE
K944571 · Northgate Technologies, Inc. · Mar 1995
RIWOLITH 2280 PROBES
K931755 · Richard Wolf Medical Instruments Corp. · Apr 1994