HGK — Endoscope, Fetal Blood Sampling (And Accessories) Class II

FDA Device Classification

FDA product code HGK covers "Endoscope, Fetal Blood Sampling (And Accessories)", a Class II medical device regulated under 21 CFR 884.1660. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
HGK
Device Class
Class II
Regulation Number
884.1660
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K954982karl storz endoscopy-americaKSEA SCALP BLOOD COLLECTION SETJuly 17, 1996