Cleared Traditional

K932261 - ES-100 ACCESSORIES

K932261 is an FDA 510(k) clearance for ES-100 ACCESSORIES, manufactured by Elekta Instruments, Inc.. The device is a Class 1 Orthopedic device with product code HWE cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K932261 · Elekta Instruments, Inc. · Orthopedic device
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Jan 1994
Decision
262d
Days
Class 1
Risk

K932261 is an FDA 510(k) clearance for the ES-100 ACCESSORIES. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Elekta Instruments, Inc. (Tucker, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 262 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Elekta Instruments, Inc. devices

FDA 510(k) Submission Details - K932261

510(k) Number K932261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1993
Decision Date January 07, 1994
Days to Decision 262 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 122d · This submission: 262d
Pathway characteristics
Predicate-based equivalence.

HWE Device Classification - Class 1, General Controls

Product Code HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
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 - HWE Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment

All 51
Devices cleared under the same product code (HWE) and FDA review panel - the closest regulatory comparables to K932261.
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OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
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