Cleared Traditional

KARL STORZ 27086KC ULTRASONIC LITHOTRI (K843101) - FDA 510(k) Clearance

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

K843101 · KARL STORZ Endoscopy-America, Inc. · Gastroenterology & Urology device
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Dec 1984
Decision
126d
Days
Class 2
Risk

K843101 is an FDA 510(k) clearance for the KARL STORZ 27086KC ULTRASONIC LITHOTRI. 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 December 11, 1984 after a review of 126 days - within the typical 510(k) review window.

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 K843101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1984
Decision Date December 11, 1984
Days to Decision 126 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 130d · This submission: 126d
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 K843101.
Swiss LthoClast Trilogy
K230893 · E.M.S Electro Medical Systems S.A · Oct 2023
Swiss LithoClast Trilogy
K182490 · E.M.S Electro Medical Systems S.A · Oct 2018
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
KSEA CALCUSON
K973251 · KARL STORZ Endoscopy-America, Inc. · Jun 1998