Cleared Traditional

K913815 - AUTOMATED BIOPSY DEVICE, MODIFICATION (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K913815 · Hart Enterprises, Inc. · General & Plastic Surgery device
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Oct 1991
Decision
65d
Days
Class 1
Risk

K913815 is an FDA 510(k) clearance for the AUTOMATED BIOPSY DEVICE, MODIFICATION. Classified as Needle, Biopsy, Cardiovascular (product code DWO), Class I - General Controls.

Submitted by Hart Enterprises, Inc. (Wyoming, US). The FDA issued a Cleared decision on October 30, 1991 after a review of 65 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 Hart Enterprises, Inc. devices

Submission Details

510(k) Number K913815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date October 30, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 114d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DWO Needle, Biopsy, Cardiovascular
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.