Cleared Traditional

K873370 - ALLEN MALLEABLE ANESTHESIA SCREEN

K873370 is an FDA 510(k) clearance for ALLEN MALLEABLE ANESTHESIA SCREEN, manufactured by Edgewater Medical Equipment Systems. The device is a Class 1 General & Plastic Surgery device with product code FWZ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K873370 · Edgewater Medical Equipment Systems · General & Plastic Surgery device
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Sep 1987
Decision
21d
Days
Class 1
Risk

K873370 is an FDA 510(k) clearance for the ALLEN MALLEABLE ANESTHESIA SCREEN. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by Edgewater Medical Equipment Systems (Mayfield Hts., US). The FDA issued a Cleared decision on September 11, 1987 after a review of 21 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 Edgewater Medical Equipment Systems devices

FDA 510(k) Submission Details - K873370

510(k) Number K873370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1987
Decision Date September 11, 1987
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 K873370.
SECOND ASSISTANT
K890501 · 3M Company · Feb 1989
SPINAL SURGERY FRAME
K882078 · Karlin Technology, Inc. · Jun 1988
WEHBE ARM HOLDER
K880265 · Orthopedic Systems, Inc. · Feb 1988
HAND SURGERY TABLE EXTENSION
K871225 · Orthopedic Systems, Inc. · Apr 1987
LITHOTOMY HOLDERS
K870098 · Orthopedic Systems, Inc. · Feb 1987
CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION
K870101 · Orthopedic Systems, Inc. · Feb 1987