Cleared Traditional

K842475 - RICHARDS INTRA-ARTICULAR SHAVER MOTOR

K842475 is an FDA 510(k) clearance for RICHARDS INTRA-ARTICULAR SHAVER MOTOR, manufactured by Richards Medical Co., Inc.. The device is a Class 1 General & Plastic Surgery device with product code GEY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K842475 · Richards Medical Co., Inc. · General & Plastic Surgery device
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Sep 1984
Decision
84d
Days
Class 1
Risk

K842475 is an FDA 510(k) clearance for the RICHARDS INTRA-ARTICULAR SHAVER MOTOR. Classified as Motor, Surgical Instrument, Ac-powered (product code GEY), Class I - General Controls.

Submitted by Richards Medical Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1984 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K842475

510(k) Number K842475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1984
Decision Date September 17, 1984
Days to Decision 84 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 115d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

GEY Device Classification - Class 1, General Controls

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.

Regulatory Peers - GEY Motor, Surgical Instrument, Ac-powered

All 18
Devices cleared under the same product code (GEY) and FDA review panel - the closest regulatory comparables to K842475.
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