Cleared Traditional

K971498 - APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE (FDA 510(k) Clearance)

Class I Gastroenterology & Urology device.

K971498 · Applied Medical Resources · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
10d
Days
Class 1
Risk

K971498 is an FDA 510(k) clearance for the APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE. Classified as Stylet For Catheter, Gastro-urology (product code EZB), Class I - General Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on May 5, 1997 after a review of 10 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

Submission Details

510(k) Number K971498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1997
Decision Date May 05, 1997
Days to Decision 10 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 130d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EZB Stylet For Catheter, Gastro-urology
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 876.5130
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.