Cleared Traditional

(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE (K863385) - FDA 510(k) Clearance

Class I Physical Medicine device.

K863385 · Cook Urological, Inc. · Physical Medicine device
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Nov 1986
Decision
62d
Days
Class 1
Risk

K863385 is an FDA 510(k) clearance for the (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on November 4, 1986 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - the FDA physical medicine 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 Cook Urological, Inc. devices

Submission Details

510(k) Number K863385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date November 04, 1986
Days to Decision 62 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KNN Components, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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.