Needle, Membrane
FDA 510(k) K770528 · American Viggo
510(k) numberK770528
Submission
- Device name
- Needle, Membrane
- Applicant
- American Viggo
Walker, MI, US - Received
- March 18, 1977
- Decision date
- April 29, 1977
- 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
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 |
|---|---|---|
| K771339 | Male Luer Lock PlugFPA · Traditional | 08/02/1977SE |
| K770181 | I.V. Catheter Placement UnitFOZ · Traditional | 03/30/1977SE |
| K770174 | Luer-Lock Extension SetFPK · Traditional | 03/30/1977SE |
| K770154 | 3-WAY Stopcock with Luer-Lock FittingKGZ · Traditional | 02/28/1977SE |
| K770096 | Epidural Block Procedure PackCAZ · Traditional | 02/25/1977SE |
| K760679 | 4-WAY Stopcock W/7CM Tubing,FMG · Traditional | 12/02/1976SE |
| K760678 | 4-WAY Stopcock W/100 CM Tubing, Luer-LkFMG · Traditional | 12/02/1976SE |
| K760667 | 4-WAY Stopcock W/10 CM Exten. TubingFMG · Traditional | 12/02/1976SE |
| K760666 | 4-WAY Stopcock W/Luer-Lock FittingFMG · Traditional | 12/02/1976SE |
Questions and answers
When was Needle, Membrane cleared by the FDA?
Needle, Membrane (K770528) received a 510(k) decision of Substantially Equivalent on April 29, 1977, 42 days after the submission was received.
What is the product code of K770528?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.