Cleared Traditional

K942660 - HALL MICROCHOICE ELECTRIC POWERED SYSTEM (FDA 510(k) Clearance)

Class I Orthopedic device.

K942660 · Hall Surgical, Division of Zimmer, Inc. · Orthopedic device
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Sep 1994
Decision
93d
Days
Class 1
Risk

K942660 is an FDA 510(k) clearance for the HALL MICROCHOICE ELECTRIC POWERED SYSTEM. Classified as Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment (product code HWE), Class I - General Controls.

Submitted by Hall Surgical, Division of Zimmer, Inc. (Carpinteria, US). The FDA issued a Cleared decision on September 7, 1994 after a review of 93 days - within the typical 510(k) review window.

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 Hall Surgical, Division of Zimmer, Inc. devices

Submission Details

510(k) Number K942660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1994
Decision Date September 07, 1994
Days to Decision 93 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
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.