MTW — System, Water, Reproduction, Assisted, And Purification Class II

FDA Device Classification

FDA product code MTW covers "System, Water, Reproduction, Assisted, And Purification", a Class II medical device regulated under 21 CFR 884.6170. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MTW
Device Class
Class II
Regulation Number
884.6170
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K011598irvine scientific sales coWATER FOR ASSISTED REPRODUCTIVE TECHNOLOGIES (A.R.T.) USEJune 13, 2001
K993140conception technologiesWATER FOR TISSUE CULTURE, MODELS 1500August 2, 2000