Cleared Traditional

K941010 - ACUCISE GUIDEWIRE EXCHANGE SHEATH

K941010 is an FDA 510(k) clearance for ACUCISE GUIDEWIRE EXCHANGE SHEATH, manufactured by Applied Medical Resources. The device is a Class 2 Gastroenterology & Urology device with product code EYB cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K941010 · Applied Medical Resources · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
46d
Days
Class 2
Risk

K941010 is an FDA 510(k) clearance for the ACUCISE GUIDEWIRE EXCHANGE SHEATH. Classified as Catheter, Ureteral, Gastro-urology (product code EYB), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on April 18, 1994 after a review of 46 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 Applied Medical Resources devices

FDA 510(k) Submission Details - K941010

510(k) Number K941010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1994
Decision Date April 18, 1994
Days to Decision 46 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
84d faster than avg
Panel avg: 130d · This submission: 46d
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 21
Devices cleared under the same product code (EYB) and FDA review panel - the closest regulatory comparables to K941010.
AQ HYDROPHILIC UROLOGICAL CATHETERS
K962004 · Cook Urological, Inc. · Jun 1996
BARD FLEXIBLE TIP URETERAL CATHETER
K950300 · C.R. Bard, Inc. · Apr 1995
ACU-SIZER(TM)
K941011 · Applied Medical Resources · Jun 1994
LOW PRESSURE TAMPONADE BALLOON CATHETER
K941012 · Applied Medical Resources · Apr 1994
MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER
K933020 · Boston Scientific Corp · Jan 1994
URETERAL CATHETER
K923729 · Cook Urological, Inc. · Dec 1993