Cleared Traditional

ARTHRO-PREP REST W/STAND (K812395) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K812395 · Northwest Surgical Concepts, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.