Surmodics,Inc.
Surmodics,Inc. appears in FDA public data with 0 recalls, 11 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Sep 24, 2025.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 5
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252227 | Pounce(TM) Sheath | Sep 24, 2025 |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | Sep 11, 2024 |
| K232647 | Microcatheter | Sep 29, 2023 |
| K231828 | Pounce Sheath | Sep 7, 2023 |
| K231022 | Pounce Thrombectomy System | Jun 12, 2023 |
| K221886 | Sublime Microcatheter | Oct 14, 2022 |
| K220501 | Pounce Thrombectomy System | Mar 23, 2022 |
| K211492 | Pounce Thrombectomy System | Jul 30, 2021 |
| K192814 | Pounce Thrombus Retrieval System | Sep 21, 2020 |
| K190644 | Guide Sheath | Apr 18, 2019 |
| K173560 | Microcatheter | Jan 12, 2018 |