# K231022: Pounce™ Thrombectomy System

- Pathway: 510(k) (Traditional)
- Applicant: Surmodics,Inc.
- Decided: Jun 12, 2023 after 63 days
- Product code: QEW (Peripheral Mechanical Thrombectomy With Aspiration)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970657 (1997). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220501: Pounce Thrombectomy System, Surmodics,Inc. (2022) Summary page 4.

## Most influential descendants
- K260599: INDIGO® Aspiration System – INDIGO Link (2026), 0 descendants of its own
- K241362: Pounce XL Thrombectomy System (PTS-1011-7F135) (2024), 0 descendants of its own

## Indications for use
The Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature. The Pounce LP Thrombectomy System is indicated for use in vessels ranging from 2 mm to 4 mm in diameter.

Source page: https://510kreport.com/device/K231022
Methodology: https://510kreport.com/methodology