Amipaque Myelogram Tray
FDA 510(k) K791156 · Pharmaseal Div., Baxter Healthcare Corp.
510(k) numberK791156
Submission
- Device name
- Amipaque Myelogram Tray
- Applicant
- Pharmaseal Div., Baxter Healthcare Corp.
Mchenry, IL, US - Received
- June 21, 1979
- Decision date
- July 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
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|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K792369 | Hyperalimentation Dressing TrayFRG · Traditional | 12/10/1979SE |
| K792141 | Continuous Flush DeviceKRA · Traditional | 12/05/1979SE |
| K792019 | Phadecode Xa Inhibitor AssayJBQ · Traditional | 11/05/1979SE |
| K791773 | Ventilator Tube with FilterCAH · Traditional | 10/22/1979SE |
| K790896 | Two-Way Anesthesia FilterCAH · Traditional | 06/05/1979SE |
| K790409 | Low Dead Space Insulin SyringeFMF · Traditional | 04/24/1979SE |
| K782069 | Tray, Auxillary BlockCAZ · Traditional | 01/04/1979SE |
| K781797 | Prep Tray, Preoperative SkinOJU · Traditional | 11/08/1978SE |
| K781680 | Monitoring, Pressure KitDRS · Traditional | 10/06/1978SE |
| K780887 | Improved Disposable Hypodermic NeedleGAA · Traditional | 06/22/1978SE |
Questions and answers
When was Amipaque Myelogram Tray cleared by the FDA?
Amipaque Myelogram Tray (K791156) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 39 days after the submission was received.
What is the product code of K791156?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.