Cleared Traditional

WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE

K981889 · Worldwide Medical Technologies, LLC · Gastroenterology & Urology

Jul 1998

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K981889 is an FDA 510(k) clearance for the WORLDWIDE MEDICAL TECHNOLOGIES INTRODUCER NEEDLE, a Biopsy Needle (Class II — Special Controls, product code FCG), submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on July 31, 1998, 63 days after receiving the submission on May 29, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number	K981889 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 29, 1998
Decision Date	July 31, 1998
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement