10CC Control Syringe
FDA 510(k) K873588 · Medi-Plast Intl., Inc.
510(k) numberK873588
Submission
- Device name
- 10CC Control Syringe
- Applicant
- Medi-Plast Intl., Inc.
Roswell, GA, US - Received
- September 4, 1987
- Decision date
- October 23, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954284 | Medi-Plast 2 Port Manifold (Right on)DTL · Traditional | 02/12/1996SE |
| K863402 | Medi-Plast Disposable ManifoldDTL · Traditional | 10/22/1986SE |
| K861785 | Fluoroscope Band BagJAA · Traditional | 06/13/1986SE |
| K851489 | Arterial-Venous Compression Dressing · Traditional | 06/11/1985SE |
| K842136 | Sterile Pan SetFRG · Traditional | 07/06/1984SE |
| K840021 | Operating Room Tray SetFSM · Traditional | 03/15/1984SE |
| K840022 | Heart Catheterization Tray SetDRE · Traditional | 02/04/1984SE |
| K811268 | Bottle-To-BottleKPE · Traditional | 06/18/1981SE |
| K811234 | I.V. Bottle (Ridgid)KPE · Traditional | 06/18/1981SE |
| K811233 | I.V. Plastic BagKPE · Traditional | 06/17/1981SE |
Questions and answers
When was 10CC Control Syringe cleared by the FDA?
10CC Control Syringe (K873588) received a 510(k) decision of Substantially Equivalent on October 23, 1987, 49 days after the submission was received.
What is the product code of K873588?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.