Cleared Traditional

REPROCESSED DISPOSABLE TROCARS

K013987 · Adven Medical · Ear, Nose, Throat

Mar 2002

Decision

87d

Days

Class 1

Risk

About This 510(k) Submission

K013987 is an FDA 510(k) clearance for the REPROCESSED DISPOSABLE TROCARS, a Trocar, Sinus (Class I — General Controls, product code KBG), submitted by Adven Medical (Lubbock, US). The FDA issued a Cleared decision on March 1, 2002, 87 days after receiving the submission on December 4, 2001. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K013987 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2001
Decision Date	March 01, 2002
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF