Cleared Traditional

K850168 - STILLE SCANDIA OPERATING TABLES RC 3000,1100

K850168 is an FDA 510(k) clearance for STILLE SCANDIA OPERATING TABLES RC 3000, manufactured by Stille-Werner (Usa), Inc.. The device is a Class 1 General & Plastic Surgery device with product code GDC cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K850168 · Stille-Werner (Usa), Inc. · General & Plastic Surgery device
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Mar 1985
Decision
71d
Days
Class 1
Risk

K850168 is an FDA 510(k) clearance for the STILLE SCANDIA OPERATING TABLES RC 3000,1100. Classified as Table, Operating-room, Electrical (product code GDC), Class I - General Controls.

Submitted by Stille-Werner (Usa), Inc. (Ronkonkoma, US). The FDA issued a Cleared decision on March 28, 1985 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4960 - 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 Stille-Werner (Usa), Inc. devices

FDA 510(k) Submission Details - K850168

510(k) Number K850168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1985
Decision Date March 28, 1985
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

GDC Device Classification - Class 1, General Controls

Product Code GDC Table, Operating-room, Electrical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
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 - GDC Table, Operating-room, Electrical

All 14
Devices cleared under the same product code (GDC) and FDA review panel - the closest regulatory comparables to K850168.
MAYFIELD TABLE-ELECTRIC
K851021 · Ohio Medical Instrument Co., Inc. · May 1985
SKYTRON ELITE 3100 SURGICAL TABLE
K851829 · Skytron, Div. the Kmw Group, Inc. · May 1985
SKYTRON ELITE 7000 MICRO-SURGERY TABLE
K851830 · Skytron, Div. the Kmw Group, Inc. · May 1985
AMSCO ENDOSCOPY TABLE
K821749 · American Sterilizer Co. · Jul 1982