Cleared Traditional

K971801 - LAPAROTOMY BLADDER NECK SUSPENSION KIT

K971801 is the FDA 510(k) clearance for LAPAROTOMY BLADDER NECK SUSPENSION KIT by Louisville Laboratories, Inc.. It is a Class 2 Gastroenterology & Urology device (product code EZL) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K971801 · Louisville Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
68d
Days
Class 2
Risk

K971801 is an FDA 510(k) clearance for the LAPAROTOMY BLADDER NECK SUSPENSION KIT. Classified as Catheter, Retention Type, Balloon (product code EZL), Class II - Special Controls.

Submitted by Louisville Laboratories, Inc. (North Attleboro, US). The FDA issued a Cleared decision on July 22, 1997 after a review of 68 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 Louisville Laboratories, Inc. devices

Submission Details

510(k) Number K971801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1997
Decision Date July 22, 1997
Days to Decision 68 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 130d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZL Catheter, Retention Type, Balloon
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 - EZL Catheter, Retention Type, Balloon

All 59
Devices cleared under the same product code (EZL) and FDA review panel - the closest regulatory comparables to K971801.
KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C
K990500 · The Kendal Co. · Sep 1999
RUSCH BRILLANT SILICONE FOLEY CATHETER
K972184 · Rusch Intl. · Jan 1998
RUSCH BRILLANT BALLOON CATHETER
K971643 · Rusch Intl. · Oct 1997
SYMPACATH HYDROGEL COATED FOLEY
K964575 · Rusch Intl. · Feb 1997
EUROPHILIC SLIPPERY COATED FOLEY CATHETER
K944007 · Baxter Healthcare Corp · Jun 1995
SILICONE FOLEY CATHETER
K951106 · Cook Urological, Inc. · May 1995