Cleared Traditional

K813030 - O.R. ARMBOARD COVER

K813030 is an FDA 510(k) clearance for O.R. ARMBOARD COVER, manufactured by Tecnol New Jersey Wound Care, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FWZ cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K813030 · Tecnol New Jersey Wound Care, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
82d
Days
Class 1
Risk

K813030 is an FDA 510(k) clearance for the O.R. ARMBOARD COVER. Classified as Operating Room Accessories Table Tray (product code FWZ), Class I - General Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Hammonton, US). The FDA issued a Cleared decision on January 18, 1982 after a review of 82 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 Tecnol New Jersey Wound Care, Inc. devices

FDA 510(k) Submission Details - K813030

510(k) Number K813030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1981
Decision Date January 18, 1982
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
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 K813030.
ARTHROSCOPY SYSTEM LEG HOLDER
K821029 · Zimmer, Inc. · Apr 1982
ANTHROSCOPIC SURGICAL TABLE
K820289 · The Anspach Effort, Inc. · Apr 1982
KNEE SUPPORT FOR X-RAY & SURGERY
K820291 · The Anspach Effort, Inc. · Mar 1982
THE SURGICAL ASSISTANT
K790674 · Instrument Makar, Inc. · May 1979
TABLE, HAND SURGI
K760456 · Stryker Corp. · Nov 1976