Cleared Traditional

K933020 - MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER

K933020 is an FDA 510(k) clearance for MOD. PHANTOM 5 PLUS UROL. BALLOON DILAT..., manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code EYB cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K933020 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
195d
Days
Class 2
Risk

K933020 is an FDA 510(k) clearance for the MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER. Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on January 3, 1994 after a review of 195 days - an extended review 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: 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K933020

510(k) Number K933020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date January 03, 1994
Days to Decision 195 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
64d slower than avg
Panel avg: 131d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EYB Device Classification - Class 2, Special Controls

Product Code EYB Catheter, Ureteral, Gastro-urology
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 - EYB Catheter, Ureteral, Gastro-urology

All 22
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K933020.
ACU-SIZER(TM)
K941011 · Applied Medical Resources · Jun 1994
ACUCISE GUIDEWIRE EXCHANGE SHEATH
K941010 · Applied Medical Resources · Apr 1994
LOW PRESSURE TAMPONADE BALLOON CATHETER
K941012 · Applied Medical Resources · Apr 1994
URETERAL CATHETER
K923729 · Cook Urological, Inc. · Dec 1993
URETERAL CATHETER
K930483 · Surgitek · Jul 1993
ENCAPSULATED GUIDEWIRE WITH FLEXIBLE TIP
K914358 · Hobbs Medical, Inc. · Nov 1991