Cleared Traditional

K972857 - SERVOTRONIC EC100 SYSTEM

K972857 is an FDA 510(k) clearance for SERVOTRONIC EC100 SYSTEM, manufactured by Medicon EG. The device is a Class 2 Neurology device with product code HBC cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K972857 · Medicon EG · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
168d
Days
Class 2
Risk

K972857 is an FDA 510(k) clearance for the SERVOTRONIC EC100 SYSTEM. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by Medicon EG (Washington, US). The FDA issued a Cleared decision on January 16, 1998 after a review of 168 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4360 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medicon EG devices

FDA 510(k) Submission Details - K972857

510(k) Number K972857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1997
Decision Date January 16, 1998
Days to Decision 168 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 148d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBC Device Classification - Class 2, Special Controls

Product Code HBC Motor, Drill, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4360
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.