Gainor Medical Syringe
FDA 510(k) K844306 · Gainor Medical
510(k) numberK844306
Submission
- Device name
- Gainor Medical Syringe
- Applicant
- Gainor Medical
- Received
- November 6, 1984
- Decision date
- November 30, 1984
- 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 |
|---|---|---|
| K850100 | Blood LancetFMK · Traditional | 01/29/1987SE |
| K850150 | Ulster Scientific, Inc. Autolet Lancets/Gainor MedFMK · Traditional | 02/21/1985SE |
| K844305 | Gainor Medical Flowmax NeedlesFMI · Traditional | 11/30/1984SE |
| K840951 | First Aid BandageKGX · Traditional | 10/31/1984SE |
| K840950 | Zinc Oxide TapeKGX · Traditional | 10/31/1984SE |
| K840945 | Skin ClosureFPX · Traditional | 10/31/1984SE |
| K840949 | Clear Plastic-HypoallergenicKGX · Traditional | 08/17/1984SE |
| K840947 | Cloth-HypoallergenicKGX · Traditional | 08/17/1984SE |
| K840946 | Microporous HypoallergenicKGW · Traditional | 08/17/1984SE |
| K840948 | Clear Porous Plastic-HypoallergenicGKX · Traditional | 08/14/1984SE |
Questions and answers
When was Gainor Medical Syringe cleared by the FDA?
Gainor Medical Syringe (K844306) received a 510(k) decision of Substantially Equivalent on November 30, 1984, 24 days after the submission was received.
What is the product code of K844306?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.