Cleared Traditional

K860446 - C ARM SURGICAL TABLE

K860446 is an FDA 510(k) clearance for C ARM SURGICAL TABLE, manufactured by Medi-Mech, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FWZ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K860446 · Medi-Mech, Inc. · General & Plastic Surgery device
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Mar 1986
Decision
34d
Days
Class 1
Risk

K860446 is an FDA 510(k) clearance for the C ARM SURGICAL TABLE. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by Medi-Mech, Inc. (The Dalles, US). The FDA issued a Cleared decision on March 10, 1986 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4950 - 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 Medi-Mech, Inc. devices

FDA 510(k) Submission Details - K860446

510(k) Number K860446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date March 10, 1986
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

FWZ Device Classification - Class 1, General Controls

Product Code FWZ Operating Room Accessories Table Tray
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 - FWZ Operating Room Accessories Table Tray

All 26
Devices cleared under the same product code (FWZ) and FDA review panel - the closest regulatory comparables to K860446.
RADIOLUCENT TABLE EXTENSION
K870104 · Orthopedic Systems, Inc. · Feb 1987
COLLINS POSITIONING DEVICE
K864880 · Orthopedic Systems, Inc. · Dec 1986
ARTHROSCOPIC ANKLE HOLDER
K864881 · Orthopedic Systems, Inc. · Dec 1986
BASILDON-GARDNER SPINAL FRAME
K842700 · Downs Surgical , Ltd. · Sep 1984
ULNAR NERVE PROTECTOR
K840421 · Devon Industries, Inc. · Mar 1984
DEVON HEAD REST
K840422 · Devon Industries, Inc. · Mar 1984