ECLIPSE SYSTEM
FDA 510(k) clearance DEN140020 · decided 2015-02-12
Clearance details
- K-number
- DEN140020
- Device name
- ECLIPSE SYSTEM
- Applicant
- Pelvalon
- Decision
- Unknown
- Date received
- 2014-06-24
- Decision date
- 2015-02-12
- Days to decision
- 233 days
- Clearance type
- Direct
- Product code
- PJH
- Device class
- 2
- Regulation number
- 876.5930
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Hillsborough, CA, US
- Third-party review
- No
- Expedited review
- Yes
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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 (K150558) | Pelvalon, Inc. | 2015-11-12 |
Recalls involving this device
No recalls on record reference this clearance.