Tembo Embolic System
FDA 510(k) K253677 · Instylla, Inc.
510(k) numberK253677
Submission
- Device name
- Tembo Embolic System
- Applicant
- Instylla, Inc.
Bedford, MA, US - Received
- November 21, 2025
- Decision date
- December 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code KRD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252812 | UniPearls® Embolic MicrospheresKRD · Traditional | Suzhou Haowei Medical Technology Co., Ltd. | 07/31/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | Boston Scientific Corporation | 07/24/2026SE |
| K261866 | Concerto Versa Detachable CoilKRD · Special | Medtronic, Inc. | 06/24/2026SE |
| K260635 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 06/12/2026SE |
| K260508 | LOBO Vascular Occlusion SystemKRD · Traditional | Okami Medical, Inc. | 04/10/2026SE |
| K253511 | Concerto Versa Detachable CoilKRD · Traditional | Medtronic, Inc. | 01/14/2026SE |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
| K250133 | HARBOR Occlusion DeviceKRD · Traditional | Nuvascular, Inc. | 07/09/2025SE |
| K251383 | Prestige Coil System (Prestige Packing Line Extension)KRD · Special | Balt USA, LLC | 05/30/2025SE |
More from Balt USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K261610 | Verge MicrocatheterKRA · Special | 06/11/2026SE |
| K253769 | Instylla Delivery KitFMF · Special | 12/22/2025SE |
| 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 |
| K202544 | Instylla Delivery KitFMF · Special | 01/07/2021SE |
| 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 Tembo Embolic System cleared by the FDA?
Tembo Embolic System (K253677) received a 510(k) decision of Substantially Equivalent on December 15, 2025, 24 days after the submission was received.
What is the product code of K253677?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.