Cleared Traditional

SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (K910783) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K910783 · Smith & Nephew Equipment Group · General & Plastic Surgery device
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Apr 1991
Decision
36d
Days
Class 1
Risk

K910783 is an FDA 510(k) clearance for the SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M. Classified as Table And Attachments, Operating-room (product code BWN), Class I - General Controls.

Submitted by Smith & Nephew Equipment Group (St. Louis, US). The FDA issued a Cleared decision on April 2, 1991 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - 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 Smith & Nephew Equipment Group devices

Submission Details

510(k) Number K910783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1991
Decision Date April 02, 1991
Days to Decision 36 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 115d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BWN Table And Attachments, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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.