Cleared Traditional

K800609 - CATHETER STYLET

K800609 is an FDA 510(k) clearance for CATHETER STYLET, manufactured by G.D. Searle and Co.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K800609 · G.D. Searle and Co. · Gastroenterology & Urology device
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Apr 1980
Decision
24d
Days
Class 2
Risk

K800609 is an FDA 510(k) clearance for the CATHETER STYLET. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - 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 G.D. Searle and Co. devices

FDA 510(k) Submission Details - K800609

510(k) Number K800609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date April 10, 1980
Days to Decision 24 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 130d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 - KOD Catheter, Urological

All 129
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K800609.
URINE COLLECTION CONTAINERS, #3600 &3610
K801786 · The Healthcare Group Laboratories, Inc. · Sep 1980
LATEX FOLEY CATHETER (HYDROMER COATED)
K801415 · G.D. Searle and Co. · Aug 1980
URINARY CATHETERS #3400,3410 &3420
K801784 · The Healthcare Group Laboratories, Inc. · Aug 1980
FOLEY CATHETER
K800306 · Abco Dealers, Inc. · Feb 1980
IRRIGATION (3-WAY) FOLEY CATHETER
K800307 · Abco Dealers, Inc. · Feb 1980
PEDIATRIC FOLEY CATHETER
K800308 · Abco Dealers, Inc. · Feb 1980