RNS Sterile, Disposable Amniocentesis Tray
FDA 510(k) K955679 · Contour Fabricators of Florida, Inc.
510(k) numberK955679
Submission
- Device name
- RNS Sterile, Disposable Amniocentesis Tray
- Applicant
- Contour Fabricators of Florida, Inc.
Palm Harobor, FL, US - Received
- December 14, 1995
- Decision date
- March 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HIO – Sampler, Amniotic Fluid (Amniocentesis Tray)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 884.1550
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960203 | G.E. Sterile Amniocentesis TrayHIO · Traditional | GE Medical Systems | 03/14/1996SE |
| K914419 | Amniotest(Tm)HIO · Traditional | Pro-Lab, Inc. | 09/01/1993SE |
| K922960 | Various Cameo Med Amniocentesis Trays, DisposableHIO · Traditional | Cameo, Inc. | 11/05/1992SEKD |
| K921738 | Sono-Vu Us(Tm), ModificationHIO · Traditional | E-Z-Em, Inc. | 04/27/1992SE |
| K915863 | Mega Amniocentesis KitHIO · Traditional | Mega Medical, Inc. | 03/30/1992SEKD |
| K904583 | Sono-Vu Us(Tm)HIO · Traditional | E-Z-Em, Inc. | 06/24/1991SE |
| K901643 | Isoflo(Tm) Amniocentesis TrayHIO · Traditional | Healthdyne Cardiovascular, Inc. | 07/25/1990SE |
| K900021 | Percu-Set(Tm)HIO · Traditional | E-Z-Em, Inc. | 03/29/1990SE |
| K896031 | Amniotic Fluid Sampler (Amniocentesis Tray)HIO · Traditional | Concord/Portex | 01/12/1990SE |
| K894031 | Pharmaseal Genetic Amniocentesis TrayHIO · Traditional | Baxter Healthcare Corp | 08/04/1989SESD |
More from Baxter Healthcare Corp
| 510(k) | Device | Decision |
|---|---|---|
| K955685 | RNS Sterile, Disposable CT Biopsy TrayDXT · Traditional | 10/04/1996SE |
| K962040 | RNS Arthrogram TrayFMI · Traditional | 06/25/1996SE |
| K955687 | RNS Sterile, Disposable Radiographic Contrast TrayJAA · Traditional | 06/03/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | 05/15/1996SE |
| K955684 | RNS Sterile, Disposable Angiographic TrayDXT · Traditional | 05/02/1996SESK |
| K955688 | RNS Sterile, Disposable Standard Biopsy TrayFRG · Traditional | 02/21/1996SE |
| K955686 | RNS, Sterile Disposable Percutaneous Cholangiographic TrayFRG · Traditional | 02/21/1996SE |
| K955678 | RNS Sterile Disposable Puncture TrayFRG · Traditional | 02/21/1996SE |
| K955683 | RNS Sterile, Disposable Breast Biopsy/Localization TrayMJG · Traditional | 02/01/1996SE |
| K952396 | Redi Nurse System (RNS) Sterile 0.9% Sodium Chloride SolutionBSY · Traditional | 08/15/1995SE |
Questions and answers
When was RNS Sterile, Disposable Amniocentesis Tray cleared by the FDA?
RNS Sterile, Disposable Amniocentesis Tray (K955679) received a 510(k) decision of Substantially Equivalent on March 12, 1996, 89 days after the submission was received.
What is the product code of K955679?
The FDA product code is HIO – Sampler, Amniotic Fluid (Amniocentesis Tray), a Class I (low risk) device regulated under 21 CFR 884.1550.