Cleared Traditional

K061679 - WALLACE ARTIFICIAL INSEMINATION CATHETER
(FDA 510(k) Clearance)

K061679 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology

Oct 2006

Decision

120d

Days

Class 2

Risk

K061679 is an FDA 510(k) clearance for the WALLACE ARTIFICIAL INSEMINATION CATHETER, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 13, 2006, 120 days after receiving the submission on June 15, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K061679 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2006
Decision Date	October 13, 2006
Days to Decision	120 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF