Cleared Traditional

KERRISON RONGEURS (K943583) - FDA 510(k) Clearance

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

K943583 · Enterprise Medical Corp. · Neurology device
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Feb 1995
Decision
214d
Days
Class 2
Risk

K943583 is an FDA 510(k) clearance for the KERRISON RONGEURS. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Enterprise Medical Corp. (Greensboro, US). The FDA issued a Cleared decision on February 21, 1995 after a review of 214 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Enterprise Medical Corp. devices

Submission Details

510(k) Number K943583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1994
Decision Date February 21, 1995
Days to Decision 214 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 148d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
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 Neurology devices follow this clearance model.

Regulatory Peers - HAE Rongeur, Manual

All 35
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