Cleared Traditional

K863385 - (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY ...

K863385 is the FDA 510(k) clearance for (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY ... by Cook Urological, Inc.. It is a Class 1 Physical Medicine device (product code KNN) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - KNN Components, Wheelchair

All 7
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K863385.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
K211919 · Kinetic Innovative Seating System, LLC · Mar 2022
CUSHION, WHELCHAR AND FLOTATION
K915629 · Invacare Corp. · Jan 1992
VAN-TEC PROSTATE BIOPSY NEEDLE
K870698 · Van-Tec, Inc. · Mar 1987
ARM THROUGH FOR WHEELCHAIR BK-6458-01
K823637 · Fred Sammons, Inc. · Jan 1983
ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
K823638 · Fred Sammons, Inc. · Jan 1983
BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR
K813636 · Fred Sammons, Inc. · Jan 1982