Cleared Traditional

K052387 - ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX (FDA 510(k) Clearance)

Class I General Hospital device.

K052387 · Arthrex, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
90d
Days
Class 1
Risk

K052387 is an FDA 510(k) clearance for the ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX. Classified as Finger Cot (product code LZB), Class I - General Controls.

Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on November 29, 2005 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Arthrex, Inc. devices

Submission Details

510(k) Number K052387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2005
Decision Date November 29, 2005
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZB Finger Cot
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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.