GraftGun Universal Graft Delivery System (GDS)
FDA 510(k) K243580 · SurGenTec, LLC
510(k) numberK243580
Submission
- Device name
- GraftGun Universal Graft Delivery System (GDS)
- Applicant
- SurGenTec, LLC
Boca Raton, FL, US - Received
- November 19, 2024
- Decision date
- February 5, 2025
- 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 |
More from Instylla, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262581 | GraftGun Universal Graft Delivery System (GDS®)FMF · Special | 08/26/2026SE |
| K261381 | TiLink-L SI Joint Fusion SystemOUR · Traditional | 08/24/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | 07/24/2026SE |
| K261209 | Ion-LMRW · Traditional | 06/11/2026SE |
| K260329 | Ion-C Navigation InstrumentsOLO · Traditional | 05/22/2026SE |
| K253604 | TiLink-L Navigation InstrumentsOLO · Traditional | 03/20/2026SE |
| K251714 | Ion-CMRW · Traditional | 01/16/2026SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | 07/02/2025SE |
| K243949 | OsteoFlo HydroFiberMQV · Traditional | 05/28/2025SE |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW · Traditional | 04/24/2025SE |
Questions and answers
When was GraftGun Universal Graft Delivery System (GDS) cleared by the FDA?
GraftGun Universal Graft Delivery System (GDS) (K243580) received a 510(k) decision of Substantially Equivalent on February 5, 2025, 78 days after the submission was received.
What is the product code of K243580?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.