Cleared Traditional

K875043 - RONGEUR (NEUROSURGICAL INSTRUMENTS)

K875043 is an FDA 510(k) clearance for RONGEUR (NEUROSURGICAL INSTRUMENTS), manufactured by Solway, Inc.. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K875043 · Solway, Inc. · Neurology device
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Jan 1988
Decision
51d
Days
Class 2
Risk

K875043 is an FDA 510(k) clearance for the RONGEUR (NEUROSURGICAL INSTRUMENTS). Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Solway, Inc. (Hollywood, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 51 days - a notably fast clearance 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: 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 Solway, Inc. devices

FDA 510(k) Submission Details - K875043

510(k) Number K875043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1987
Decision Date January 22, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 148d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAE Device Classification - Class 2, Special Controls

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.