Cleared Traditional

K911388 - CAVOMAT

K911388 is an FDA 510(k) clearance for CAVOMAT, manufactured by Wiest USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code IKN cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K911388 · Wiest USA, Inc. · Gastroenterology & Urology device
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Dec 1991
Decision
250d
Days
Class 2
Risk

K911388 is an FDA 510(k) clearance for the CAVOMAT. Classified as Electromyograph, Diagnostic (product code IKN), Class II - Special Controls.

Submitted by Wiest USA, Inc. (Potomac, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 250 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 890.1375 - 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 Wiest USA, Inc. devices

FDA 510(k) Submission Details - K911388

510(k) Number K911388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date December 04, 1991
Days to Decision 250 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 130d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKN Device Classification - Class 2, Special Controls

Product Code IKN Electromyograph, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1375
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 - IKN Electromyograph, Diagnostic

All 17
Devices cleared under the same product code (IKN) and FDA review panel - the closest regulatory comparables to K911388.
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KC/EMG DIAGNOSTIC ELECTROMYOGRAPH
K864630 · Chattanooga Group, Inc. · Dec 1986
EMG MODULES FOR POLYGRAPH SYSTEM
K823562 · Nihon Kohden America, Inc. · Jan 1983