Eclipse System
FDA 510(k) clearance K150558 · decided 2015-11-12
Clearance details
- K-number
- K150558
- Device name
- Eclipse System
- Applicant
- Pelvalon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-04
- Decision date
- 2015-11-12
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- PJH
- Device class
- 2
- Regulation number
- 876.5930
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sunnyvale, CA, 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 |
|---|---|---|
| ECLIPSE SYSTEM (DEN140020) | Pelvalon | 2015-02-12 |
Recalls involving this device
No recalls on record reference this clearance.