Cleared Traditional

KSEA CALCUSON (K973251) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973251 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
297d
Days
Class 2
Risk

K973251 is an FDA 510(k) clearance for the KSEA CALCUSON. Classified as Lithotriptor, Ultrasonic (product code FEO), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on June 22, 1998 after a review of 297 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K973251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1997
Decision Date June 22, 1998
Days to Decision 297 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
167d slower than avg
Panel avg: 130d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEO Lithotriptor, Ultrasonic
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 - FEO Lithotriptor, Ultrasonic

All 13
Devices cleared under the same product code (FEO) and FDA review panel - the closest regulatory comparables to K973251.
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Swiss LithoClast Trilogy
K181997 · E.M.S Electro Medical Systems S.A · Aug 2018
Swiss LithoClast Trilogy
K181364 · E.M.S Electro Medical Systems S.A · Jun 2018
Swiss LithoClast Trilogy
K173234 · E.M.S Electro Medical Systems S.A · Jan 2018
KARL STORZ 27086KC ULTRASONIC LITHOTRI
K843101 · KARL STORZ Endoscopy-America, Inc. · Dec 1984