Instylla Delivery Kit
FDA 510(k) K202544 · Instylla, Inc.
510(k) numberK202544
Submission
- Device name
- Instylla Delivery Kit
- Applicant
- Instylla, Inc.
Bedford, MA, US - Received
- September 2, 2020
- Decision date
- January 7, 2021
- 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
| 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 |
|---|---|---|
| K261610 | Verge MicrocatheterKRA · Special | 06/11/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | 12/22/2025SE |
| K253677 | Tembo Embolic SystemKRD · Special | 12/15/2025SE |
| K240873 | TEMBO Embolic SystemKRD · Traditional | 12/16/2024SE |
| K213632 | Instylla Delivery KitFMF · Special | 02/10/2022SE |
| K210808 | Instylla Microcatheter 1.2KRA · Special | 04/15/2021SE |
| K200744 | Instylla MicrocatheterKRA · Special | 04/21/2020SE |
| K191659 | Instylla Delivery KitFMF · Traditional | 10/10/2019SE |
| K191731 | Instylla MicrocatheterKRA · Traditional | 08/13/2019SE |
Questions and answers
When was Instylla Delivery Kit cleared by the FDA?
Instylla Delivery Kit (K202544) received a 510(k) decision of Substantially Equivalent on January 7, 2021, 127 days after the submission was received.
What is the product code of K202544?
The FDA product code is FMF – Syringe, Piston, a Class II (moderate risk) device regulated under 21 CFR 880.5860.