Cleared Traditional

K843134 - MOBILE OPERATING TABLE HEIDELBERGS 1130

K843134 is an FDA 510(k) clearance for MOBILE OPERATING TABLE HEIDELBERGS 1130, 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 29-day FDA review.

K843134 · Stierlen-Maquet AG · General & Plastic Surgery device
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Sep 1984
Decision
29d
Days
Class 1
Risk

K843134 is an FDA 510(k) clearance for the MOBILE OPERATING TABLE HEIDELBERGS 1130. Classified as Table, Operating-room, Electrical (product code GDC), Class I - General Controls.

Submitted by Stierlen-Maquet AG (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 after a review of 29 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 - K843134

510(k) Number K843134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1984
Decision Date September 07, 1984
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 K843134.
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