Cleared Traditional

K944754 - AMPLATZ SUPER STIFF GUIDEWIRE

K944754 is an FDA 510(k) clearance for AMPLATZ SUPER STIFF GUIDEWIRE, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KNY cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K944754 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
11d
Days
Class 2
Risk

K944754 is an FDA 510(k) clearance for the AMPLATZ SUPER STIFF GUIDEWIRE. Classified as Accessories, Catheter, G-u (product code KNY), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on October 7, 1994 after a review of 11 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K944754

510(k) Number K944754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1994
Decision Date October 07, 1994
Days to Decision 11 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
120d faster than avg
Panel avg: 131d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNY Device Classification - Class 2, Special Controls

Product Code KNY Accessories, Catheter, G-u
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 - KNY Accessories, Catheter, G-u

All 38
Devices cleared under the same product code (KNY) and FDA review panel - the closest regulatory comparables to K944754.
MANAN MANTA CATHETER FIXATION DISK
K954132 · Manan Medical Products, Inc. · Mar 1996
KENDALL CURITY CATHETER PLUG WITH PROTECTIVE CAP
K951488 · The Kendal Co. · Apr 1995
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
K943835 · Orion Life Systems, Inc. · Jan 1995
UROLOGICAL GUIDWIRE
K944135 · Applied Medical Resources · Sep 1994
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
K934072 · Contour Fabricators of Florida, Inc. · Sep 1994
ZEBRA UROLOGICAL GUIDEWIRE
K942205 · Boston Scientific Corp · Jul 1994