Cleared Traditional

K863385 - (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE

K863385 is an FDA 510(k) clearance for (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY ..., manufactured by Cook Urological, Inc.. The device is a Class 1 Physical Medicine device with 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.

FDA 510(k) Submission Details - K863385

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
54d faster than avg
Panel avg: 116d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

KNN Device Classification - Class 1, General Controls

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 57
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K863385.
LIFESTYLE SOF. CARE GEL CHAIR CUSHION
K882012 · Gaymar Industries, Inc. · May 1988
VAN-TEC PROSTATE BIOPSY NEEDLE
K870698 · Van-Tec, Inc. · Mar 1987
REDMAN UPHOLSTERY SERIES FOR WHEELCHAIRS
K870299 · Redman, Inc. · Feb 1987
UPHOLSTERED BUCKET SEAT
K862887 · Mednet, Inc. · Aug 1986
THE FITZ KIT, MOLDED/CUSTOM WHEELCHAIR SEATING SYS
K861751 · Special Health Systems, Ltd. · May 1986
KINESETHETIC SEATING SYSTEM/WHEELCHAIR
K861754 · Special Health Systems, Ltd. · May 1986
K863385 · (ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
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