Cleared Traditional

K954699 - BRAY RONGEUR

K954699 is an FDA 510(k) clearance for BRAY RONGEUR, manufactured by Johnson & Johnson Professionals, Inc.. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K954699 · Johnson & Johnson Professionals, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
55d
Days
Class 2
Risk

K954699 is an FDA 510(k) clearance for the BRAY RONGEUR. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raritan, US). The FDA issued a Cleared decision on December 6, 1995 after a review of 55 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 Johnson & Johnson Professionals, Inc. devices

FDA 510(k) Submission Details - K954699

510(k) Number K954699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1995
Decision Date December 06, 1995
Days to Decision 55 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 148d · This submission: 55d
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.

Regulatory Peers - HAE Rongeur, Manual

All 25
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K954699.
BAXANO ULTRA LOW PROFILE RONGEUR
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MICROBLADE SHAVER AND ACCESSORIES
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ULTRA LOW PROFILE RONGEUR
K062711 · Baxano, Inc. · Mar 2007
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116 · United States Surgical, A Division of Tyco Healthc · Jul 1994
NEUROLOGICAL RONGEURS - VARIOUS TYPES
K892535 · Zinnanti Surgical Instruments, Inc. · May 1989