HIO · Sampler, Amniotic Fluid (Amniocentesis Tray)
Obstetrics/Gynecology · 21 CFR 884.1550 · Class 1
Overview
| Product Code | HIO |
|---|---|
| Device Name | Sampler, Amniotic Fluid (Amniocentesis Tray) |
| Regulation | 21 CFR 884.1550 |
| Device Class | Class 1 |
| Review Panel | Obstetrics/Gynecology |
Identification
The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960203 | G.E. STERILE AMNIOCENTESIS TRAY | GE Medical Systems | Mar 14, 1996 | SESE |
| K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | Contour Fabricators of Florida, Inc. | Mar 12, 1996 | SESE |
| K914419 | AMNIOTEST(TM) | Pro-Lab, Inc. | Sep 1, 1993 | SESE |
| K922960 | VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE | Cameo, Inc. | Nov 5, 1992 | SEKD |
| K921738 | SONO-VU US(TM), MODIFICATION | E-Z-Em, Inc. | Apr 27, 1992 | SESE |
| K915863 | MEGA AMNIOCENTESIS KIT | Mega Medical, Inc. | Mar 30, 1992 | SEKD |
| K904583 | SONO-VU US(TM) | E-Z-Em, Inc. | Jun 24, 1991 | SESE |
| K901643 | ISOFLO(TM) AMNIOCENTESIS TRAY | Healthdyne Cardiovascular, Inc. | Jul 25, 1990 | SESE |
| K900021 | PERCU-SET(TM) | E-Z-Em, Inc. | Mar 29, 1990 | SESE |
| K896031 | AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) | Concord/Portex | Jan 12, 1990 | SESE |
| K894031 | PHARMASEAL GENETIC AMNIOCENTESIS TRAY | Baxter Healthcare Corp | Aug 4, 1989 | SESD |
| K892846 | ECHO-TIP DISPOSABLE AMNIOCENTESIS NEEDLE | Cook Ob/Gyn | Jul 14, 1989 | SESE |
| K890463 | ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY | Critical Specialties, Inc. | Apr 7, 1989 | SESD |
| K862365 | NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE | Swemed Laboratories, Inc. | Jul 7, 1986 | SESE |
| K854725 | HURWITZ AMNIOCENTESIS NEEDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 17, 1986 | SESE |
| K850632 | PMS AMNIOCENTESIS TRAY/KIT | Professional Medical Services | May 22, 1985 | SESE |
| K844558 | UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE | Universal Medical Instrument Corp. | Jan 31, 1985 | SESE |
| K830019 | AMNIO CENTESES KIT W/NEEDLE | Universal Medical Instrument Corp. | Jan 18, 1983 | SESE |
| K802666 | APTEK ULTRASOUND PROCEDURE TRAY | Aptek , Ltd. | Nov 26, 1980 | SESE |
| K761230 | AMMOCENTESIS TRAY (KIT) | Pharmaseal Div., Baxter Healthcare Corp. | Dec 17, 1976 | SESE |
Top Applicants
- E-Z-Em, Inc. — 3 clearances
- Universal Medical Instrument Corp. — 2 clearances
- Aptek , Ltd. — 1 clearance
- Baxter Healthcare Corp — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
