Surmodics, Inc.
Eden Prairie, MN, US
SURMODICS, INC. appears in FDA device records in Eden Prairie, MN. FDA records list 11 510(k) clearances between and , 7 PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Surmodics, Inc. between 2018 and 2025. The busiest year on record is 2023, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252227 | Pounce(TM) Sheath | DYB | Substantially Equivalent | |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135) | QEW | Substantially Equivalent | |
| K232647 | Microcatheter | DQY | Substantially Equivalent | |
| K231828 | Pounce™ Sheath | DYB | Substantially Equivalent | |
| K231022 | Pounce™ Thrombectomy System | QEW | Substantially Equivalent | |
| K221886 | Sublime Microcatheter | DQY | Substantially Equivalent | |
| K220501 | Pounce Thrombectomy System | QEW | Substantially Equivalent | |
| K211492 | Pounce Thrombectomy System | QEW | Substantially Equivalent | |
| K192814 | Pounce Thrombus Retrieval System | QEW | Substantially Equivalent | |
| K190644 | Guide Sheath | DYB | Substantially Equivalent | |
| K173560 | Microcatheter | DQY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001374820 | 3001374820 | SURMODICS, INC. | 9924 W 74th St, EDEN PRAIRIE, MN 55344 US | 2026 | |
| 3014687026 | 3014687026 | SURMODICS, INC. | 7905 Golden Triangle Drive Suite 190, Eden Prairie, MN 55344 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain