esolution
FDA 510(k) clearance DEN230006 · decided 2023-09-06
Clearance details
- K-number
- DEN230006
- Device name
- esolution
- Applicant
- S4 Medical Corp.
- Decision
- Unknown
- Date received
- 2023-01-24
- Decision date
- 2023-09-06
- Days to decision
- 225 days
- Clearance type
- Direct
- Product code
- QXU
- Device class
- 2
- Regulation number
- 870.5710
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chagrin Falls, OH, US
- 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 |
|---|---|---|
| esolution® Esophageal Retractor (K243233) | S4 Medical Corp. | 2024-11-09 |
Recalls involving this device
No recalls on record reference this clearance.