Torpedo Gelatin Foam
FDA 510(k) K183578 · Biosphere Medical, S.A.
510(k) numberK183578
Submission
- Device name
- Torpedo Gelatin Foam
- Applicant
- Biosphere Medical, S.A.
Roissy-En-France, FR - Received
- December 21, 2018
- Decision date
- June 18, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K253677 | Tembo Embolic SystemKRD · Special | Instylla, Inc. | 12/15/2025SE |
| 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 |
More from Nuvascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250971 | Embosphere MicrospheresKRD · Traditional | 05/16/2025SE |
| K192480 | Torpedo Gelatin FoamKRD · Traditional | 11/21/2019SE |
| K183120 | EmboCube Embolization GelatinKRD · Traditional | 08/06/2019SE |
| K181021 | EmboCube Embolization GelatinKRD · Traditional | 09/27/2018SE |
| K181300 | Embosphere MicrospheresKRD · Traditional | 07/16/2018SE |
| K172372 | QuadraSphere MicrospheresKRD · Special | 09/06/2017SE |
| K153102 | QuadraSphere MicrospheresKRD · Special | 11/23/2015SE |
| K151187 | QuadraSphere MicrospheresKRD · Traditional | 07/27/2015SE |
Questions and answers
When was Torpedo Gelatin Foam cleared by the FDA?
Torpedo Gelatin Foam (K183578) received a 510(k) decision of Substantially Equivalent on June 18, 2019, 179 days after the submission was received.
What is the product code of K183578?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.