Cleared Traditional

K954717 - SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY

K954717 is an FDA 510(k) clearance for SODEM HIGH SPEED SYSTEM FOR NEUROSURGER..., manufactured by Sodem Diffusion SA. The device is a Class 2 Neurology device with product code HBB cleared through the Traditional 510(k) pathway after a 467-day FDA review.

K954717 · Sodem Diffusion SA · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
467d
Days
Class 2
Risk

K954717 is an FDA 510(k) clearance for the SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Sodem Diffusion SA (North Attleboro, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 467 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Sodem Diffusion SA devices

FDA 510(k) Submission Details - K954717

510(k) Number K954717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1995
Decision Date January 22, 1997
Days to Decision 467 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
319d slower than avg
Panel avg: 148d · This submission: 467d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBB Device Classification - Class 2, Special Controls

Product Code HBB Motor, Drill, Pneumatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4370
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 - HBB Motor, Drill, Pneumatic

All 22
Devices cleared under the same product code (HBB) and FDA review panel - the closest regulatory comparables to K954717.
TRITON HUDSON CHUCK ATTACHMENT
K983092 · Mednext, Inc. · Nov 1998
AESCULAP HILAN MOTOR SYSTEM
K980686 · Aesculap, Inc. · Sep 1998
MIDAS REX MOTOR
K972289 · Midas Rex Pneumatic Tools, Inc. · Sep 1997
ANSPAHC SPEED REDUCER
K960630 · The Anspach Effort, Inc. · Nov 1996
MIDAS REX III MOTOR
K962483 · Midas Rex Pneumatic Tools, Inc. · Nov 1996
MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)
K953434 · Midas Rex Pneumatic Tools, Inc. · May 1996