ANKYRAS
FDA 510(k) clearance K250160 · decided 2025-05-06
Clearance details
- K-number
- K250160
- Device name
- ANKYRAS
- Applicant
- Mentice Spain S.L.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-21
- Decision date
- 2025-05-06
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- PZO
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Barcelona, ES
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Sim&Size (K253122) | Sim&Cure | 2025-12-23 |
| Sim&Size (K242124) | Sim&Cure | 2024-12-14 |
| Ankyras (K230006) | Mentice Spain S.L. | 2023-12-28 |
| Sim&Size (K222664) | Sim&Cure | 2023-01-27 |
| AneuGuide (K213838) | ArteryFlow Technology Co., Ltd. | 2022-06-01 |
| Sim&Size (K212373) | Sim&Cure | 2022-01-27 |
| Sim&Size (K202322) | Sim&Cure | 2020-12-31 |
| Sim&Size (K190049) | Sim&Cure | 2019-09-17 |
| SurgicalPreview (K171534) | Endo Vantage, LLC | 2017-11-08 |
Recalls involving this device
No recalls on record reference this clearance.