Cleared Traditional

K981233 - KSEA CALCUSPLIT

K981233 is an FDA 510(k) clearance for KSEA CALCUSPLIT, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FFK cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K981233 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
73d
Days
Class 2
Risk

K981233 is an FDA 510(k) clearance for the KSEA CALCUSPLIT. Classified as Lithotriptor, Electro-hydraulic (product code FFK), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 15, 1998 after a review of 73 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K981233

510(k) Number K981233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1998
Decision Date June 15, 1998
Days to Decision 73 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
58d faster than avg
Panel avg: 131d · This submission: 73d
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 K981233.
SWISS LITHOCLAST MULTIPURPOSE PROBE
K992251 · Electro Medical Systems SA · Jul 1999
ELECTRO MECHANICAL LITHOTRIPTOR
K990341 · Northgate Technologies, Inc. · Jul 1999
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
K980492 · Circon Acmi · Nov 1998
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