Cleared Traditional

K833624 - SHUTT UNIVERSAL STRESS POST

K833624 is an FDA 510(k) clearance for SHUTT UNIVERSAL STRESS POST, manufactured by Concept, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FWZ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K833624 · Concept, Inc. · General & Plastic Surgery device
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Nov 1983
Decision
45d
Days
Class 1
Risk

K833624 is an FDA 510(k) clearance for the SHUTT UNIVERSAL STRESS POST. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 28, 1983 after a review of 45 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 Concept, Inc. devices

FDA 510(k) Submission Details - K833624

510(k) Number K833624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1983
Decision Date November 28, 1983
Days to Decision 45 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 115d · This submission: 45d
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 20
Devices cleared under the same product code (FWZ) and FDA review panel - the closest regulatory comparables to K833624.
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
ELEVATOR CUSHION
K832472 · Inmed Corp. · Sep 1983
ACUFEX UNIVERSAL LEG HOLDER
K830707 · Acufex Microsurgical, Inc. · May 1983
ARTHROSCOPY SYSTEM LEG HOLDER
K821029 · Zimmer, Inc. · Apr 1982