GPS Advanced; GPS Advanced Cannula
FDA 510(k) K251648 · Prosidyan, Inc.
510(k) numberK251648
Submission
- Device name
- GPS Advanced; GPS Advanced Cannula
- Applicant
- Prosidyan, Inc.
New Providence, NJ, US - Received
- May 29, 2025
- Decision date
- June 24, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | 10/22/2025SE |
| K241426 | GPS Advanced; 5 cc GPS Advanced CannulaFMF · Traditional | 07/10/2024SE |
| K213803 | FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteMQV · Traditional | 08/23/2022SE |
| K182670 | FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteMQV · Traditional | 12/20/2018SE |
| K180080 | FIBERGRAFT BG Matrix Bone Graft SubstituteMQV · Traditional | 04/06/2018SE |
| K171284 | FIBERGRAFT BG Matrix Bone Graft SubstituteMQV · Traditional | 06/30/2017SE |
| K170306 | FIBERGRAFT BG Putty Bone Graft SubstituteMQV · Traditional | 05/24/2017SE |
| K151154 | FIBERGRAFT BG MorselsMQV · Traditional | 11/10/2015SE |
| K143533 | Fibergraft BG Putty Bone Graft SubstituteMQV · Traditional | 03/25/2015SE |
| K141956 | Fibergraft BG MorselsMQV · Special | 08/13/2014SE |
Questions and answers
When was GPS Advanced; GPS Advanced Cannula cleared by the FDA?
GPS Advanced; GPS Advanced Cannula (K251648) received a 510(k) decision of Substantially Equivalent on June 24, 2025, 26 days after the submission was received.
What is the product code of K251648?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.