Product code HIO— Obstetrics/Gynecology
AMMOCENTESIS TRAY (KIT)
- Classification name
- Sampler, Amniotic Fluid (Amniocentesis Tray)
- Device class
- Class 1
- Regulation
- 21 CFR 884.1550
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code HIO
FDA has cleared devices under product code HIO between 1976 and 1996, filed by 17 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1996
- 1993
- 1992
- 1991
- 1990
- 1989
- 1986
- 1985
- 1983
- 1980
- 1976
Top applicants under product code HIO
Recent clearances under product code HIO
- K960203 — G.E. STERILE AMNIOCENTESIS TRAY
- K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
- K914419 — AMNIOTEST(TM)
- K922960 — VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
- K921738 — SONO-VU US(TM), MODIFICATION
- K915863 — MEGA AMNIOCENTESIS KIT
- K904583 — SONO-VU US(TM)
- K901643 — ISOFLO(TM) AMNIOCENTESIS TRAY
- K900021 — PERCU-SET(TM)
- K896031 — AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
- K894031 — PHARMASEAL GENETIC AMNIOCENTESIS TRAY
- K892846 — ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE
- K890463 — ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY
- K862365 — NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE
- K854725 — HURWITZ AMNIOCENTESIS NEEDLE
- K850632 — PMS AMNIOCENTESIS TRAY/KIT
- K844558 — UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE
- K830019 — AMNIO CENTESES KIT W/NEEDLE
- K802666 — APTEK ULTRASOUND PROCEDURE TRAY
- K761230 — AMMOCENTESIS TRAY (KIT)
Data sourced from openFDA. This site is unofficial and independent of the FDA.