Cleared Traditional

K883613 - OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.

K883613 is an FDA 510(k) clearance for OPER. TABLE FOR PERCUTAN. TRANS. CORONA..., manufactured by Stierlen-Maquet AG. The device is a Class 1 General & Plastic Surgery device with product code GDC cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K883613 · Stierlen-Maquet AG · General & Plastic Surgery device
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Sep 1988
Decision
24d
Days
Class 1
Risk

K883613 is an FDA 510(k) clearance for the OPER. TABLE FOR PERCUTAN. TRANS. CORONARY ANGIO.. Classified as Table, Operating-room, Electrical (product code GDC), Class I - General Controls.

Submitted by Stierlen-Maquet AG (West Germany, GR). The FDA issued a Cleared decision on September 15, 1988 after a review of 24 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 Stierlen-Maquet AG devices

FDA 510(k) Submission Details - K883613

510(k) Number K883613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1988
Decision Date September 15, 1988
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
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 K883613.
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