Cleared Traditional

K953597 - NOPROFILE OLBERT CATHETER SYSTEM BALLOO...

K953597 is the FDA 510(k) clearance for NOPROFILE OLBERT CATHETER SYSTEM BALLOO... by Meadox Medicals, Div. Boston Scientific Corp.. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K953597 · Meadox Medicals, Div. Boston Scientific Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
67d
Days
Class 2
Risk

K953597 is an FDA 510(k) clearance for the NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on October 7, 1995 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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 Meadox Medicals, Div. Boston Scientific Corp. devices

Submission Details

510(k) Number K953597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date October 07, 1995
Days to Decision 67 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
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 43
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K953597.
ASCEND BALLOON DAILATION CATHETER
K970041 · Cook Urological, Inc. · Mar 1997
BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER
K962921 · C.R. Bard, Inc. · Oct 1996
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
K953691 · Meadox Medicals, Div. Boston Scientific Corp. · Oct 1995
DILATATION CATHETER, BALLOON
K953004 · Boston Scientific Corp · Sep 1995
MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)
K945576 · Meadox Medicals, Div. Boston Scientific Corp. · Jan 1995
PASSPORT
K941853 · Boston Scientific Corp · Sep 1994