Cleared Traditional

STERILE SOFT TISSUE BIOPSY NEEDLE (K854003) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K854003 · Co-Medical, Inc. · General & Plastic Surgery device
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Oct 1985
Decision
18d
Days
Class 1
Risk

K854003 is an FDA 510(k) clearance for the STERILE SOFT TISSUE BIOPSY NEEDLE. Classified as Brush, Biopsy, General & Plastic Surgery (product code GEE), Class I - General Controls.

Submitted by Co-Medical, Inc. (Lakewood, US). The FDA issued a Cleared decision on October 18, 1985 after a review of 18 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Co-Medical, Inc. devices

Submission Details

510(k) Number K854003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1985
Decision Date October 18, 1985
Days to Decision 18 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
97d faster than avg
Panel avg: 115d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GEE Brush, Biopsy, General & Plastic Surgery
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.