iTind System
FDA 510(k) clearance K210138 · decided 2021-06-25
Clearance details
- K-number
- K210138
- Device name
- iTind System
- Applicant
- Medi-Tate , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-19
- Decision date
- 2021-06-25
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- QKA
- Device class
- 2
- Regulation number
- 876.5510
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hadera, IL
- 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 |
|---|---|---|
| Urocross Expander System (UES-2018-C1) (K261342) | Prodeon Medical, Inc. | 2026-06-22 |
| Urocross Expander System (Model Numbers ES2018 and ES3025) (K253525) | Prodeon Medical, Inc. | 2026-03-12 |
| iTind System (DEN190020) | Medi-Tate , Ltd. | 2020-02-25 |
Recalls involving this device
No recalls on record reference this clearance.