Cleared Traditional

K903401 - SPECIAL RONGEUR

K903401 is an FDA 510(k) clearance for SPECIAL RONGEUR, manufactured by Sur-Med Instruments, Inc.. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K903401 · Sur-Med Instruments, Inc. · Neurology device
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Aug 1990
Decision
10d
Days
Class 2
Risk

K903401 is an FDA 510(k) clearance for the SPECIAL RONGEUR. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Sur-Med Instruments, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 10, 1990 after a review of 10 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 Sur-Med Instruments, Inc. devices

FDA 510(k) Submission Details - K903401

510(k) Number K903401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date August 10, 1990
Days to Decision 10 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 148d · This submission: 10d
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 14
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K903401.
JARIT, RUGGLES, R&B REDMOND/ REDMOND, MILTEX, MEISTERHAND - KERRISON RONGEURS
K092227 · Integra Lifesciences Corp. · Feb 2010
BRAY RONGEUR
K954699 · Johnson & Johnson Professionals, Inc. · Dec 1995
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