Cleared Traditional

WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE

K011598 · Irvine Scientific Sales Co., Inc. · Obstetrics & Gynecology

Jun 2001

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K011598 is an FDA 510(k) clearance for the WATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USE, a System, Water, Reproduction, Assisted, And Purification (Class II — Special Controls, product code MTW), submitted by Irvine Scientific Sales Co., Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 13, 2001, 20 days after receiving the submission on May 24, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6170.

Submission Details

510(k) Number	K011598 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 24, 2001
Decision Date	June 13, 2001
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF