Cleared Traditional

K970807 - MOBILE OPERATING TABLE 1132.01

K970807 is an FDA 510(k) clearance for MOBILE OPERATING TABLE 1132.01, 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 9-day FDA review.

K970807 · Stierlen-Maquet AG · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
9d
Days
Class 1
Risk

K970807 is an FDA 510(k) clearance for the MOBILE OPERATING TABLE 1132.01. Classified as Table, Operating-room, Electrical (product code GDC), Class I - General Controls.

Submitted by Stierlen-Maquet AG (Rastatt, DE). The FDA issued a Cleared decision on March 14, 1997 after a review of 9 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 - K970807

510(k) Number K970807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1997
Decision Date March 14, 1997
Days to Decision 9 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Tuv Product Service, Inc.
CAROLE STAMP

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GDC Table, Operating-room, Electrical

All 13
Devices cleared under the same product code (GDC) and FDA review panel - the closest regulatory comparables to K970807.
QUANTUM 3080SP SURGICAL TABLE
K971390 · STERIS Corporation · May 1997
DURA-BOARD ARMBOARD
K964273 · Allen Medical Systems, Inc. · Jan 1997
SKYTRON ELITE 3500 TABLE
K940616 · Skytron, Div. the Kmw Group, Inc. · Jun 1994
MIDMARK MAGNUM GENERAL SURGICAL TABLE
K934744 · Midmark Corp. · Mar 1994
MDT/SHAMPAINE MODEL 4900B SURGICAL TABLE
K914758 · Mdt Corp., Inc. · Dec 1991
MDT/SHAMPAINE MODEL 4900E SURGICAL TABLE
K915393 · Mdt Corp., Inc. · Dec 1991

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.