Cleared Traditional

K963506 - TENET RADIOLUCENT HAND TABLE

K963506 is an FDA 510(k) clearance for TENET RADIOLUCENT HAND TABLE, manufactured by Tenet Medical Engineering. The device is a Class 1 General & Plastic Surgery device with product code FQO cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K963506 · Tenet Medical Engineering · General & Plastic Surgery device
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Jan 1997
Decision
128d
Days
Class 1
Risk

K963506 is an FDA 510(k) clearance for the TENET RADIOLUCENT HAND TABLE. Classified as Table, Operating-room, Ac-powered (product code FQO), Class I - General Controls.

Submitted by Tenet Medical Engineering (Calgary, CA). The FDA issued a Cleared decision on January 9, 1997 after a review of 128 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Tenet Medical Engineering devices

FDA 510(k) Submission Details - K963506

510(k) Number K963506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date January 09, 1997
Days to Decision 128 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

FQO Device Classification - Class 1, General Controls

Product Code FQO Table, Operating-room, Ac-powered
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 - FQO Table, Operating-room, Ac-powered

All 17
Devices cleared under the same product code (FQO) and FDA review panel - the closest regulatory comparables to K963506.
OPT80 THE TRANSPORTABLE (OPT80)
K972810 · O.P.T. USA, Inc. · Aug 1997
ALLEN, ULTRA AND SMART SOCKETS
K971988 · Allen Medical Systems, Inc. · Jul 1997
AMSCO SURGICAL TABLE
K971307 · STERIS Corporation · Jun 1997
DRAGER GEMINA WALL-MOUNTED WORKPLACE
K961886 · Alm Surgical Equipment, Inc. · Jul 1996
DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM
K961742 · Alm Surgical Equipment, Inc. · Jul 1996
TELETOM
K955750 · Berchtold Holding GmbH · Feb 1996