Cleared Traditional

K980492 - AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)

K980492 is an FDA 510(k) clearance for AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND..., manufactured by Circon Acmi. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K980492 · Circon Acmi · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
281d
Days
Class 2
Risk

K980492 is an FDA 510(k) clearance for the AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F). Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by Circon Acmi (Stamford, US). The FDA issued a Cleared decision on November 17, 1998 after a review of 281 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 Circon Acmi devices

FDA 510(k) Submission Details - K980492

510(k) Number K980492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1998
Decision Date November 17, 1998
Days to Decision 281 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
150d slower than avg
Panel avg: 131d · This submission: 281d
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 K980492.
KSEA CALCUSPLIT
K992114 · Karl Storz Endoscopy · Aug 1999
SWISS LITHOCLAST MULTIPURPOSE PROBE
K992251 · Electro Medical Systems SA · Jul 1999
ELECTRO MECHANICAL LITHOTRIPTOR
K990341 · Northgate Technologies, Inc. · Jul 1999
KSEA CALCUSPLIT
K981233 · KARL STORZ Endoscopy-America, Inc. · Jun 1998
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
K974796 · Medispec, Ltd. · Mar 1998
MICROVASIVE LIPTHOTRIPSY PROBES
K973788 · Boston Scientific Corp · Jan 1998