Company · US
Surmodics,Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2018 to 2025. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2025 | K252227 | Pounce(TM) Sheath Surmodics,Inc. | DYB |
| Sep 11, 2024 | K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) Surmodics,Inc. | QEW |
| Sep 29, 2023 | K232647 | Microcatheter Surmodics,Inc. | DQY |
| Sep 7, 2023 | K231828 | Pounce Sheath Surmodics,Inc. | DYB |
| Jun 12, 2023 | K231022 | Pounce Thrombectomy System Surmodics,Inc. | QEW |
| Oct 14, 2022 | K221886 | Sublime Microcatheter Surmodics,Inc. | DQY |
| Mar 23, 2022 | K220501 | Pounce Thrombectomy System Surmodics,Inc. | QEW |
| Jul 30, 2021 | K211492 | Pounce Thrombectomy System Surmodics,Inc. | QEW |
| Sep 21, 2020 | K192814 | Pounce Thrombus Retrieval System Surmodics,Inc. | QEW |
| Apr 18, 2019 | K190644 | Guide Sheath Surmodics,Inc. | DYB |
| Jan 12, 2018 | K173560 | Microcatheter Surmodics,Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||