HGS — Catheter, Intrauterine And Introducer Class II

FDA Device Classification

FDA product code HGS covers "Catheter, Intrauterine And Introducer", a Class II medical device regulated under 21 CFR 884.2700. 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
HGS
Device Class
Class II
Regulation Number
884.2700
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K914387telos medicalTRANSCERVICAL INTRAUTERINE KITDecember 30, 1991
K905812epcom medical systemsINTRAUTERINE CATHETER SETJanuary 31, 1991