Cleared Traditional

K812395 - ARTHRO-PREP REST W/STAND

K812395 is an FDA 510(k) clearance for ARTHRO-PREP REST W/STAND, manufactured by Northwest Surgical Concepts, Inc.. The device is a Class 1 General & Plastic Surgery device with product code BWN cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K812395 · Northwest Surgical Concepts, Inc. · General & Plastic Surgery device
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Nov 1981
Decision
92d
Days
Class 1
Risk

K812395 is an FDA 510(k) clearance for the ARTHRO-PREP REST W/STAND. Classified as Table And Attachments, Operating-room (product code BWN), Class I - General Controls.

Submitted by Northwest Surgical Concepts, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1981 after a review of 92 days - within the typical 510(k) review window.

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: 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 Northwest Surgical Concepts, Inc. devices

FDA 510(k) Submission Details - K812395

510(k) Number K812395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1981
Decision Date November 20, 1981
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

BWN Device Classification - Class 1, General Controls

Product Code BWN Table And Attachments, Operating-room
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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 - BWN Table And Attachments, Operating-room

Devices cleared under the same product code (BWN) and FDA review panel - the closest regulatory comparables to K812395.
SPINAL SURGERY FRAME
K875291 · T. Korossurgical Instruments Corp. · Jan 1988
GUIDE TO THE KNEE
K843121 · Dyonics, Inc. · Sep 1984
AMSCO ORTHOGRAPHIC 2 TABLE
K823772 · American Sterilizer Co. · Jan 1983
THE IMMOBILIZER FOR OPEN & ARTHROSCOPIC
K802271 · The Anspach Effort, Inc. · Oct 1980
TECNOL STIRRUPS STRAP
K791859 · Tecnol New Jersey Wound Care, Inc. · Oct 1979