Cleared Traditional

K925360 - ES-100 POWER SYSTEM, ES-100 SERIES (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K925360 · Elekta Instruments, Inc. · General & Plastic Surgery device
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Sep 1993
Decision
320d
Days
Class 1
Risk

K925360 is an FDA 510(k) clearance for the ES-100 POWER SYSTEM, ES-100 SERIES. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Elekta Instruments, Inc. (Tucker, US). The FDA issued a Cleared decision on September 7, 1993 after a review of 320 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Elekta Instruments, Inc. devices

Submission Details

510(k) Number K925360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1992
Decision Date September 07, 1993
Days to Decision 320 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 114d · This submission: 320d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEY Motor, Surgical Instrument, Ac-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.