Cleared Traditional

K952029 - RUSCH INTERNATIONAL URODYNAMIC CATHETERS

K952029 is the FDA 510(k) clearance for RUSCH INTERNATIONAL URODYNAMIC CATHETERS by Rusch Intl.. It is a Class 2 Gastroenterology & Urology device (product code FEN) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K952029 · Rusch Intl. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
43d
Days
Class 2
Risk

K952029 is an FDA 510(k) clearance for the RUSCH INTERNATIONAL URODYNAMIC CATHETERS. Classified as Device, Cystometric, Hydraulic (product code FEN), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on June 13, 1995 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Rusch Intl. devices

Submission Details

510(k) Number K952029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date June 13, 1995
Days to Decision 43 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
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FEN Device, Cystometric, Hydraulic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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 - FEN Device, Cystometric, Hydraulic

All 10
Devices cleared under the same product code (FEN) and FDA review panel - the closest regulatory comparables to K952029.
UROPUMP TUBE & DAMPING CHAMGER
K953451 · Life-Tech Intl., Inc. · Oct 1995
UROVISION JANUS
K953353 · Life-Tech Intl., Inc. · Sep 1995
RUSCH URODYNAMIC RECTAL BALLOON CATHETER
K952573 · Rusch Intl. · Jun 1995
TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS
K940203 · Life-Tech Intl., Inc. · Mar 1994
KENDALL URODYNAMIC CATHETERS
K933399 · Kendall Healthcare Products Co. Div.Of Tyco Health · Nov 1993
SILICONE RECTAL BALLOON
K930135 · Cook Urological, Inc. · Oct 1993