Cleared Traditional

K953024 - LINDNER/GOLOMB SP INTRODUCING SOUND

K953024 is an FDA 510(k) clearance for LINDNER/GOLOMB SP INTRODUCING SOUND, manufactured by Cook Urological, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOB cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K953024 · Cook Urological, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
50d
Days
Class 2
Risk

K953024 is an FDA 510(k) clearance for the LINDNER/GOLOMB SP INTRODUCING SOUND. 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 August 18, 1995 after a review of 50 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.

FDA 510(k) Submission Details - K953024

510(k) Number K953024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1995
Decision Date August 18, 1995
Days to Decision 50 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 131d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOB Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K953024.
KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
K970969 · The Kendal Co. · Apr 1997
RUSCH SUPRAPUBIC TRAY
K970021 · Rusch, Inc. · Feb 1997
MOSS(R) STEEL BREAKAWAY(R) INTRODUCER
K945480 · Harry A. Schlakman · Aug 1995
RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE
K952187 · Rusch, Inc. · Jul 1995
DENTOLOCK
K921071 · Dentmed , Ltd. · Mar 1992
SUPRAPUBIC FLOW CONTROLLER
K904798 · Olympus Corp. · Nov 1991
K953024 · LINDNER/GOLOMB SP INTRODUCING SOUND
Download PDF FDA Summary Cook Urological, Inc.