Cleared Traditional

APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE

K971498 · Applied Medical Resources · Gastroenterology & Urology

May 1997

Decision

10d

Days

Class 1

Risk

About This 510(k) Submission

K971498 is an FDA 510(k) clearance for the APPLIED MEDICAL LAPAROSCOPIC GUIDEWIRE, a Stylet For Catheter, Gastro-urology (Class I — General Controls, product code EZB), submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on May 5, 1997, 10 days after receiving the submission on April 25, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K971498 FDA.gov
FDA Decision	Cleared 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