Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
FDA 510(k) K232950 · Perfect Medical Industry (Vn) Co., Ltd.
510(k) numberK232950
Submission
- Device name
- Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle
- Applicant
- Perfect Medical Industry (Vn) Co., Ltd.
Ho Chi Minh City, VN - Received
- September 20, 2023
- Decision date
- June 12, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMF – Syringe, Piston
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5860
- Specialty
- General Hospital
Other 510(k)s with product code FMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | SurGenTec, LLC | 08/26/2026SE |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | Sol-Millennium Medical, Inc. | 08/25/2026SE |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03)FMF · Traditional | Jiangsu Enjosim Medical Technology Co., Ltd. | 08/14/2026SE |
| K260208 | Ultra-Fine SAFETY Insulin SyringeFMF · Traditional | embecta Medical II, LLC | 07/13/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | Sol-Millennium Medical, Inc. | 06/18/2026SE |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead…FMF · Traditional | CMT Health PTE., Ltd. | 06/12/2026SE |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…FMF · Special | Hlb Lifescience Co., Ltd. | 05/21/2026SE |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)FMF · Traditional | Chirana T.Injecta,A.S. | 04/17/2026SE |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin SyringeFMF · Traditional | CMT Health PTE., Ltd. | 02/23/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | Instylla, Inc. | 12/22/2025SE |
Questions and answers
When was Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle cleared by the FDA?
Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle (K232950) received a 510(k) decision of Substantially Equivalent on June 12, 2024, 266 days after the submission was received.
What is the product code of K232950?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.