Cleared Special

K994175 - MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

K994175 is an FDA 510(k) clearance for MODIFICATION TO SODEM HIGH SPEED SYSTEM..., manufactured by Sodemsystems. The device is a Class 2 Neurology device with product code HBB cleared through the Special 510(k) pathway after a 11-day FDA review.

K994175 · Sodemsystems · Neurology device
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Dec 1999
Decision
11d
Days
Class 2
Risk

K994175 is an FDA 510(k) clearance for the MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE. Classified as Motor, Drill, Pneumatic (product code HBB), Class II - Special Controls.

Submitted by Sodemsystems (Geneva, CH). The FDA issued a Cleared decision on December 21, 1999 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4370 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K994175

510(k) Number K994175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1999
Decision Date December 21, 1999
Days to Decision 11 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d faster than avg
Panel avg: 149d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 26
Devices cleared under the same product code (HBB) and FDA review panel - the closest regulatory comparables to K994175.
ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM
K013091 · Von Zeppelin GmbH · Jan 2002
CRANIAL DRILL
K000195 · Image-Guided Neurologics, Inc. · Apr 2000
SODEM PERFORATOR DRIVE
K993851 · Sodemsystems · Dec 1999
KOMET XK-95 PERFORATOR MOTOR (MI-102)
K991625 · Komet Medical · Jul 1999
TRITON HUDSON CHUCK ATTACHMENT
K983092 · Mednext, Inc. · Nov 1998
AESCULAP HILAN MOTOR SYSTEM
K980686 · Aesculap, Inc. · Sep 1998
K994175 · MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
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