Cleared Traditional

K841511 - HAEMATURIA CATHETERS

K841511 is an FDA 510(k) clearance for HAEMATURIA CATHETERS, manufactured by Warne Surgical Products, Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K841511 · Warne Surgical Products, Ltd. · Gastroenterology & Urology device
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Jul 1984
Decision
92d
Days
Class 2
Risk

K841511 is an FDA 510(k) clearance for the HAEMATURIA CATHETERS. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Warne Surgical Products, Ltd. (Walker, US). The FDA issued a Cleared decision on July 12, 1984 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Warne Surgical Products, Ltd. devices

FDA 510(k) Submission Details - K841511

510(k) Number K841511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1984
Decision Date July 12, 1984
Days to Decision 92 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
39d faster than avg
Panel avg: 131d · This submission: 92d
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 160
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K841511.
VAN-TEC OCCLUSION BALLOON CATHETER
K841941 · Van-Tec, Inc. · Aug 1984
STERILE, FOLEY CATHETERS W/PTFE COAT
K841678 · Abco Dealers, Inc. · Jul 1984
CORPAK FOLEY CATH TRAY W/16FR. TEFLON
K841819 · Corpak Co. · Jul 1984
AMER. PHARMASEAL SILICONIZED LATEX
K841544 · American Pharmaseal Div. Ahsc · Jul 1984
UROLOGICAL CATHETER & ACCESSORIES
K841727 · Research Medical, Inc. · Jun 1984
UROLOGICAL KIT W/STERILE, WATER-FILL
K841485 · Medline Industries, Inc. · May 1984