Cleared Traditional

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY (K955174) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K955174 · Sodem Diffusion SA · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
70d
Days
Class 1
Risk

K955174 is an FDA 510(k) clearance for the SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY. Classified as Motor, Surgical Instrument, Pneumatic Powered (product code GET), Class I - General Controls.

Submitted by Sodem Diffusion SA (North Attleboro, US). The FDA issued a Cleared decision on January 22, 1996 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery 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 Sodem Diffusion SA devices

Submission Details

510(k) Number K955174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date January 22, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GET Motor, Surgical Instrument, Pneumatic Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GET Motor, Surgical Instrument, Pneumatic Powered

Devices cleared under the same product code (GET) and FDA review panel - the closest regulatory comparables to K955174.
AESCULAP POWER SYSTEM HANDPIECE
K960473 · Aesculap, Inc. · Mar 1996
AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP
K914753 · United States Surgical, A Division of Tyco Healthc · Jun 1992
MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP
K904578 · United States Surgical, A Division of Tyco Healthc · Oct 1990
STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II
K863447 · Stryker Corp. · Sep 1986