Cleared Traditional

(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET (K863120) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K863120 · Cook Urological, Inc. · Gastroenterology & Urology device
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Oct 1986
Decision
71d
Days
Class 2
Risk

K863120 is an FDA 510(k) clearance for the (STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on October 24, 1986 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - the FDA gastroenterology and urology 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 K863120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1986
Decision Date October 24, 1986
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 130d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOB Catheter, Suprapubic (and Accessories)

All 31
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K863120.
AMT Low-Profile Suprapubic Catheter & Drainage Set
K240514 · Applied Medical Technology, Inc. · Nov 2024
Cook Cystostomy Catheter Set
K181097 · Cook Incorporated · Jan 2019
One-Step Suprapubic Introducer
K182709 · Cook Incorporated · Dec 2018
O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set
K182066 · Cook Incorporated · Oct 2018