HIO · Class I · 21 CFR 884.1550

FDA Product Code HIO: Sampler, Amniotic Fluid (amniocentesis Tray)

Leading manufacturers include E-Z-Em, Inc., Baxter Healthcare Corp and GE Medical Systems.

20
Total
20
Cleared
113d
Avg days
1976
Since

FDA 510(k) Cleared Sampler, Amniotic Fluid (amniocentesis Tray) Devices (Product Code HIO)

20 devices
1–20 of 20
Cleared Mar 14, 1996
G.E. STERILE AMNIOCENTESIS TRAY
K960203
GE Medical Systems
Obstetrics & Gynecology · 58d
Cleared Apr 27, 1992
SONO-VU US(TM), MODIFICATION
K921738
E-Z-Em, Inc.
Radiology · 89d
Cleared Jun 24, 1991
SONO-VU US(TM)
K904583
E-Z-Em, Inc.
Radiology · 258d
Cleared Mar 29, 1990
PERCU-SET(TM)
K900021
E-Z-Em, Inc.
Obstetrics & Gynecology · 86d
Cleared Aug 04, 1989
PHARMASEAL GENETIC AMNIOCENTESIS TRAY
K894031
Baxter Healthcare Corp
Obstetrics & Gynecology · 59d
Cleared Jul 14, 1989
ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
K892846
Cook Ob/Gyn
Obstetrics & Gynecology · 87d
Cleared Mar 17, 1986
HURWITZ AMNIOCENTESIS NEEDLE
K854725
Bd Becton Dickinson Vacutainer Systems Preanalytic
Obstetrics & Gynecology · 115d

About Product Code HIO - Regulatory Context