Cleared Traditional

K873387 - VIDEO ARTHROSCOPE

K873387 is an FDA 510(k) clearance for VIDEO ARTHROSCOPE, manufactured by Arthropedics, Inc.. The device is a Class 1 General & Plastic Surgery device with product code HXR cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K873387 · Arthropedics, Inc. · General & Plastic Surgery device
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Nov 1987
Decision
152d
Days
Class 1
Risk

K873387 is an FDA 510(k) clearance for the VIDEO ARTHROSCOPE, 1.7MM X 55 MM. Classified as Spatula, Orthopedic (product code HXR), Class I - General Controls.

Submitted by Arthropedics, Inc. (Wallington, US). The FDA issued a Cleared decision on November 25, 1987 after a review of 152 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Arthropedics, Inc. devices

FDA 510(k) Submission Details - K873387

510(k) Number K873387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1987
Decision Date November 25, 1987
Days to Decision 152 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
37d slower than avg
Panel avg: 115d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

HXR Device Classification - Class 1, General Controls

Product Code HXR Spatula, Orthopedic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.