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Surmodics,Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252227Pounce(TM) SheathSeptember 24, 2025
K241362Pounce XL Thrombectomy System (PTS-1011-7F135)September 11, 2024
K232647MicrocatheterSeptember 29, 2023
K231828Pounce™ SheathSeptember 7, 2023
K231022Pounce™ Thrombectomy SystemJune 12, 2023
K221886Sublime MicrocatheterOctober 14, 2022
K220501Pounce Thrombectomy SystemMarch 23, 2022
K211492Pounce Thrombectomy SystemJuly 30, 2021
K192814Pounce Thrombus Retrieval SystemSeptember 21, 2020
K190644Guide SheathApril 18, 2019
K173560MicrocatheterJanuary 12, 2018