Exel Avf Single Needle
FDA 510(k) K963658 · Exel Intl.
510(k) numberK963658
Submission
- Device name
- Exel Avf Single Needle
- Applicant
- Exel Intl.
Culver City, CA, US - Received
- September 3, 1996
- Decision date
- May 5, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K992290 | Exel Injection Plug with CapFPA · Traditional | 02/23/2000SE |
| K963659 | Exel I.V. Administration SetFPA · Traditional | 12/16/1997SE |
| K926119 | Exel Huber Infusion Set Rotating WingFPA · Traditional | 08/11/1993SE |
| K904685 | Exel Huber Infusion Set Without Injection Site (Y)FPA · Traditional | 11/21/1990SE |
| K903945 | Exel A-V Fistula SetFIE · Traditional | 11/20/1990SE |
| K895770 | Exel Huber Infusion SetFPA · Traditional | 07/19/1990SE |
| K895772 | Exel Indwelling CatheterFDZ · Traditional | 02/16/1990SE |
| K895771 | Exel Spinal NeedlesFMI · Traditional | 02/16/1990SE |
| K895769 | Exel Huber NeedleFMI · Traditional | 02/16/1990SE |
| K895768 | Exel Safelet CatheterFOZ · Traditional | 02/16/1990SE |
Questions and answers
When was Exel Avf Single Needle cleared by the FDA?
Exel Avf Single Needle (K963658) received a 510(k) decision of Substantially Equivalent on May 5, 1998, 609 days after the submission was received.
What is the product code of K963658?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.