Epitomee
FDA 510(k) clearance K240544 · decided 2024-09-13
Clearance details
- K-number
- K240544
- Device name
- Epitomee
- Applicant
- Epitomee Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-02-27
- Decision date
- 2024-09-13
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- QFQ
- Device class
- 2
- Regulation number
- 876.5982
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Caesarea, 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 |
|---|---|---|
| Plenity (K230133) | Gelesis, Inc. | 2024-01-19 |
| Plenity (DEN180060) | Gelesis, Inc. | 2019-04-12 |
Recalls involving this device
No recalls on record reference this clearance.