Cleared Traditional

K052387 - ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX

K052387 is an FDA 510(k) clearance for ARTHREX FINGERSHIELD FINGER GUARD, manufactured by Arthrex, Inc.. The device is a Class 1 General Hospital device with product code LZB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K052387 · Arthrex, Inc. · General Hospital
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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

FDA 510(k) Submission Details - K052387

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LZB Device Classification - Class 1, General Controls

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.