FDA Product Code
FDA Product Code HIO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.1550
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K960203 | G.E. STERILE AMNIOCENTESIS TRAY | GE Medical Systems | 1996-03-14 | Traditional | PDF ↗ |
| K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | Contour Fabricators of Florida, Inc. | 1996-03-12 | Traditional | PDF ↗ |
| K914419 | AMNIOTEST(TM) | Pro-Lab, Inc. | 1993-09-01 | Traditional | PDF ↗ |
| K922960 | VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE | Cameo, Inc. | 1992-11-05 | Traditional | PDF ↗ |
| K921738 | SONO-VU US(TM), MODIFICATION | E-Z-Em, Inc. | 1992-04-27 | Traditional | PDF ↗ |
| K915863 | MEGA AMNIOCENTESIS KIT | Mega Medical, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K904583 | SONO-VU US(TM) | E-Z-Em, Inc. | 1991-06-24 | Traditional | PDF ↗ |
| K901643 | ISOFLO(TM) AMNIOCENTESIS TRAY | Healthdyne Cardiovascular, Inc. | 1990-07-25 | Traditional | PDF ↗ |
| K900021 | PERCU-SET(TM) | E-Z-Em, Inc. | 1990-03-29 | Traditional | PDF ↗ |
| K896031 | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) | Concord/Portex | 1990-01-12 | Traditional | PDF ↗ |
| K894031 | PHARMASEAL GENETIC AMNIOCENTESIS TRAY | Baxter Healthcare Corp | 1989-08-04 | Traditional | PDF ↗ |
| K892846 | ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE | Cook Ob/Gyn | 1989-07-14 | Traditional | PDF ↗ |
| K890463 | ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY | Critical Specialties, Inc. | 1989-04-07 | Traditional | PDF ↗ |
| K862365 | NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE | Swemed Laboratories, Inc. | 1986-07-07 | Traditional | PDF ↗ |
| K854725 | HURWITZ AMNIOCENTESIS NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-03-17 | Traditional | PDF ↗ |
| K850632 | PMS AMNIOCENTESIS TRAY/KIT | Professional Medical Services | 1985-05-22 | Traditional | PDF ↗ |
| K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | Universal Medical Instrument Corp. | 1985-01-31 | Traditional | PDF ↗ |
| K830019 | AMNIO CENTESES KIT W/NEEDLE | Universal Medical Instrument Corp. | 1983-01-18 | Traditional | PDF ↗ |
| K802666 | APTEK ULTRASOUND PROCEDURE TRAY | Aptek , Ltd. | 1980-11-26 | Traditional | PDF ↗ |
| K761230 | AMMOCENTESIS TRAY (KIT) | Pharmaseal Div., Baxter Healthcare Corp. | 1976-12-17 | Traditional | PDF ↗ |
Product code HIO · Class I · Obstetrics/Gynecology. Data: openFDA.