# Eximo Medical, Ltd.

- Location (FDA's records): Rehovot, IL
- FDA decisions: 8 (2018–2026): 8 510(k) clearances
- Names in FDA's records: Eximo Medical, Ltd. (7); Eximo Medical (1)
- Product codes: MCW (8)
- 510(k) review time since 2016: median 73 days, against 86 for FDA's reviews in the same codes and years (4 of 6 faster)
- Predicates its devices cite: 8 (7 its own); citations of its devices by later devices: 8 (7 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Spectranetics Corp.: 1 (https://510kreport.com/company/spectranetics)

## Firms that cite its devices most
- Avinger, Inc.: 1 (https://510kreport.com/company/avinger)

## Its most-cited devices
- K202835: Auryon Atherectomy System (2020), cited by 2
- K181642: B-Laser Atherectomy System (2018), cited by 2
- K233668: Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) (2023), cited by 2
- K230709: Auryon Atherectomy System (2023), cited by 1
- K220116: Auryon Atherectomy Catheters (2022), cited by 1

## Recent decisions
- K260244: Auryon Atherectomy System (Apr 10, 2026)
- K241553: Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating (Jun 27, 2024)
- K233668: Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) (Dec 15, 2023)
- K230709: Auryon Atherectomy System (Jun 9, 2023)
- K220116: Auryon Atherectomy Catheters (Sep 26, 2022)
- K221077: Auryon Atherectomy System (Jun 9, 2022)
- K202835: Auryon Atherectomy System (Dec 2, 2020)
- K181642: B-Laser Atherectomy System (Oct 5, 2018)

Source page: https://510kreport.com/company/eximo-medical